Opioid — Therapeutic Area Intelligence | Humanexa Signals

RegulatoryAugust 8, 2026

FDA Grants AP Status for Meperidine Hydrochloride Supplement

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Meperidine Hydrochloride submitted by Strides Pharma.

RegulatoryAugust 6, 2026

Fresenius Kabi Recalls Morphine Sulfate Injection Due to Labeling Error

Fresenius Kabi is recalling one lot of Morphine Sulfate Injection due to a labeling mix-up that could lead to medication errors.

RegulatoryAugust 1, 2026

FDA Grants Approval for Hydromorphone Hydrochloride ANDA076444

The FDA has granted approval for ANDA076444, a supplemental application for Hydromorphone Hydrochloride by Barr.

StrategyJuly 24, 2026

FDA Grants Approval for Methadone Hydrochloride ANDA212093 by Lannett Co Inc

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) for Methadone Hydrochloride submitted by Lannett Co Inc.

RegulatoryJuly 23, 2026

FDA Approves Supplement for Buprenorphine Hydrochloride by Rubicon Research

The FDA has approved a supplemental application for Buprenorphine Hydrochloride submitted by Rubicon Research.

RegulatoryJuly 23, 2026

FDA Grants Approval for Novitium's Tramadol Hydrochloride

The FDA has granted approval for Novitium Pharma's ANDA219647 for Tramadol Hydrochloride.

RegulatoryJuly 21, 2026

FDA Approval Letter for Morphine Sulfate by Fresenius Kabi USA

The FDA has issued an approval letter for the supplemental application of Morphine Sulfate (NDA204223) submitted by Fresenius Kabi USA.

RegulatoryJuly 16, 2026

FDA Approval Status Update for Buprenorphine Hydrochloride by Rubicon Research

The FDA has an active application (ANDA090279) for Buprenorphine Hydrochloride submitted by Rubicon Research.

StrategyJuly 12, 2026

FDA Grants Approval for Morphine Sulfate ANDA213892 by Quagen

The FDA has granted approval for ANDA213892, a generic version of Morphine Sulfate submitted by Quagen.

RegulatoryJuly 9, 2026

FDA Approval Status Update for Remifentanil Hydrochloride by Fresenius Kabi

Fresenius Kabi USA has submitted a supplemental application for Remifentanil Hydrochloride, currently under standard review.

StrategyJuly 8, 2026

Novitium Pharma's Tramadol Hydrochloride ANDA219647 Receives AP Status

Novitium Pharma's ANDA for Tramadol Hydrochloride has received an Approval Pending (AP) status from the FDA.

RegulatoryJuly 8, 2026

FDA Grants AP Status for Sufentanil Citrate ANDA074534 by Hospira

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Sufentanil Citrate submitted by Hospira.

RegulatoryJune 29, 2026

FDA Approval for Oxycodone Hydrochloride Supplement by Sun Pharma

The FDA has approved a supplement for Oxycodone Hydrochloride submitted by Sun Pharma.

RegulatoryJune 29, 2026

FDA Approval Status for Methadone Hydrochloride by ThePharmaNetwork LLC

The FDA has granted approval status (AP) for Methadone Hydrochloride under application ANDA090635 submitted by ThePharmaNetwork LLC.

RegulatoryJune 29, 2026

FDA Approves Morphine Sulfate Supplement by Actavis Elizabeth

The FDA has approved a supplement for Morphine Sulfate submitted by Actavis Elizabeth.

RegulatoryJune 29, 2026

FDA Acceptance of Supplement for Oxycodone Hydrochloride by Epic Pharma

The FDA has accepted a supplemental application for Oxycodone Hydrochloride submitted by Epic Pharma.

RegulatoryJune 29, 2026

FDA Approves Supplemental NDA for NUCYNTA (Tapentadol Hydrochloride)

The FDA has approved a supplemental NDA for NUCYNTA, indicating a new development in its regulatory status.

RegulatoryJune 29, 2026

FDA Approves Supplemental Application for Methadone Hydrochloride Intensol by Hikma

The FDA has approved a supplemental application for Methadone Hydrochloride Intensol submitted by Hikma.

RegulatoryJune 29, 2026

FDA Approval for Oxycodone Hydrochloride Supplement by Actavis Elizabeth

The FDA has approved a supplement application for Oxycodone Hydrochloride submitted by Actavis Elizabeth.

StrategyJune 29, 2026

Hikma's ANDA090964 for Oxymorphone Hydrochloride Receives AP Status

Hikma's Abbreviated New Drug Application (ANDA090964) for Oxymorphone Hydrochloride has received an Approval Pending (AP) status.

RegulatoryJune 29, 2026

FDA Approval Status Update for Hydromorphone Hydrochloride by Hikma

The FDA has issued an approval status update for Hikma's ANDA074597 for Hydromorphone Hydrochloride.

RegulatoryJune 29, 2026

FDA Accepts Supplement Application for Oxycodone Hydrochloride by Vistapharm

The FDA has accepted a supplemental application for Oxycodone Hydrochloride submitted by Vistapharm LLC.

StrategyJune 29, 2026

FDA Approval of Oxycodone Hydrochloride ANDA203823 by Lannett Co Inc

The FDA has approved the Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride submitted by Lannett Co Inc.

RegulatoryJune 29, 2026

FDA Acceptance of Supplement for Buprenorphine by Watson Labs Teva

The FDA has accepted a supplemental application for buprenorphine from Watson Labs Teva.

RegulatoryJune 29, 2026

FDA Accepts Supplemental Application for Methadone Hydrochloride by Hikma

The FDA has accepted a supplemental application for Methadone Hydrochloride submitted by Hikma.

RegulatoryJune 29, 2026

FDA Approval of Oxymorphone Hydrochloride Supplement by Actavis Elizabeth

The FDA has approved a supplemental application for Oxymorphone Hydrochloride submitted by Actavis Elizabeth.

RegulatoryJune 28, 2026

FDA Approval Status Update for PERCOCET (ANDA040330)

The FDA has updated the submission status for PERCOCET under ANDA040330 to Approved (AP) with a supplemental application.

RegulatoryJune 28, 2026

FDA Accepts Supplement Application for Teva's Morphine Sulfate

The FDA has accepted a supplemental application for Teva's Morphine Sulfate.

RegulatoryJune 28, 2026

FDA Accepts Supplement for XTAMPZA ER by Collegium Pharma

The FDA has accepted a supplemental application for XTAMPZA ER, an oxycodone-based pain management medication.

RegulatoryJune 28, 2026

FDA Approval for Morphine Sulfate Supplement by Actavis Elizabeth

The FDA has approved a supplement application for Morphine Sulfate submitted by Actavis Elizabeth.

RegulatoryJune 28, 2026

FDA Acceptance of Supplemental Application for Oxycodone Hydrochloride

The FDA has accepted a supplemental application for Oxycodone Hydrochloride submitted by HIBROW HLTHCARE.

RegulatoryJune 28, 2026

FDA Approval Letter for Oxycodone Hydrochloride ANDA204979

The FDA has issued an approval letter for Oxycodone Hydrochloride under ANDA204979 submitted by ANI Pharmaceuticals.

RegulatoryJune 28, 2026

FDA Approval for Morphine Sulfate Supplement by Strides Pharma

The FDA has approved a supplemental application for Morphine Sulfate submitted by Strides Pharma.

RegulatoryJune 28, 2026

FDA Acceptance of Supplemental Application for Hydromorphone Hydrochloride by Hikma

The FDA has accepted a supplemental application for Hydromorphone Hydrochloride submitted by Hikma.

RegulatoryJune 28, 2026

FDA Approves Supplemental Application for Methadone Hydrochloride by Vistapharm

The FDA has approved a supplemental application for Methadone Hydrochloride submitted by Vistapharm LLC.

RegulatoryJune 28, 2026

FDA Approval Status Update for Hydrocodone Bitartrate by Alvogen

The FDA has issued an approval status update for Alvogen's ANDA206986 for Hydrocodone Bitartrate.

RegulatoryJune 28, 2026

FDA Accepts Supplement for NUCYNTA ER by Collegium Pharma

The FDA has accepted a supplemental application for NUCYNTA ER, an opioid pain management medication.

RegulatoryJune 28, 2026

FDA Approval Status Update for Hydromorphone Hydrochloride Supplement

The FDA has granted an approval status of AP for the hydromorphone hydrochloride supplement submitted by Padagis US.

RegulatoryJune 28, 2026

FDA Accepts Supplemental NDA for Oxycodone Hydrochloride by Genus Lifesciences

The FDA has accepted a supplemental NDA for Oxycodone Hydrochloride submitted by Genus Lifesciences.

RegulatoryJune 28, 2026

FDA Acceptance of Supplemental NDA for Oxycodone Hydrochloride by Genus Lifesciences

The FDA has accepted a supplemental NDA for Oxycodone Hydrochloride submitted by Genus Lifesciences.

RegulatoryJune 28, 2026

FDA Accepts Supplemental Application for OxyContin by KNOA Pharma

The FDA has accepted a supplemental application for OxyContin submitted by KNOA Pharma.

RegulatoryJune 28, 2026

FDA Approval for Morphine Sulfate Supplement by Tris Pharma

The FDA has approved a supplemental application for Morphine Sulfate submitted by Tris Pharma.

StrategyJune 28, 2026

FDA Approval Letter for Morphine Sulfate by Upsher Smith Labs

The FDA has issued an approval letter for ANDA210610, indicating that Upsher Smith Labs' morphine sulfate product meets regulatory requirements.

RegulatoryJune 28, 2026

FDA Approves Supplemental NDA for OXAYDO by ZYLA

The FDA has approved a supplemental NDA for OXAYDO, an oxycodone hydrochloride product.

RegulatoryJune 28, 2026

FDA Approves Supplement for NUCYNTA (Tapentadol Hydrochloride)

The FDA has approved a supplemental application for NUCYNTA, indicating potential new uses or formulations.

StrategyJune 27, 2026

Hikma's Tapentadol Hydrochloride ANDA205057 Receives AP Status

Hikma's ANDA205057 for Tapentadol Hydrochloride has received Abbreviated Approval (AP) status from the FDA.

RegulatoryJune 27, 2026

FDA Accepts Supplemental Application for Tapentadol Hydrochloride by Novitium Pharma

The FDA has accepted a supplemental application for Tapentadol Hydrochloride submitted by Novitium Pharma.

RegulatoryJune 27, 2026

FDA Approves Supplement for Morphine Sulfate by ANI Pharmaceuticals

ANI Pharmaceuticals received FDA approval for a supplement related to Morphine Sulfate.

RegulatoryJune 27, 2026

FDA Approval for Oxycodone Hydrochloride Supplement by ABHAI LLC

The FDA has approved a supplemental application for Oxycodone Hydrochloride submitted by ABHAI LLC.

StrategyJune 27, 2026

FDA Grants AP Status for Levorphanol Tartrate ANDA213906 by Sun Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Levorphanol Tartrate submitted by Sun Pharma.

RegulatoryJune 27, 2026

FDA Acceptance of Supplement for Codeine Sulfate by Hikma

The FDA has accepted a supplemental application for Codeine Sulfate submitted by Hikma.

RegulatoryJune 27, 2026

FDA Approves Supplemental Application for Butrans by KNOA Pharma

The FDA has approved a supplemental application for Butrans, which contains buprenorphine as the active ingredient.

RegulatoryJune 26, 2026

FDA Accepts Supplemental NDA for BELBUCA by BDSI

The FDA has accepted a supplemental NDA for BELBUCA, indicating progress in its regulatory pathway.

RegulatoryJune 26, 2026

FDA Accepts Supplemental NDA for Percodan by Endo Operations

The FDA has accepted a supplemental NDA for Percodan, which contains aspirin and oxycodone hydrochloride.

RegulatoryJune 26, 2026

FDA Acceptance of Supplement for Codeine Sulfate by Hikma

The FDA has accepted a supplemental application for Codeine Sulfate from Hikma.

RegulatoryJune 26, 2026

FDA Approves Supplemental Application for Dilaudid by Rhodes Pharmaceuticals

The FDA has approved a supplemental application for Dilaudid, containing hydromorphone hydrochloride.

RegulatoryJune 26, 2026

FDA Accepts Supplement for RoxyBond by Protega Pharmaceuticals

The FDA has accepted a supplemental application for RoxyBond, an oxycodone hydrochloride product from Protega Pharmaceuticals.

RegulatoryJune 26, 2026

FDA Acceptance of Supplement Application for NUCYNTA by Collegium Pharma

The FDA has accepted the supplemental application for NUCYNTA (tapentadol hydrochloride) from Collegium Pharmaceutical.

RegulatoryJune 26, 2026

FDA Accepts Supplemental NDA for Oxycodone Hydrochloride by Vistapharm

The FDA has accepted a supplemental NDA for Oxycodone Hydrochloride submitted by Vistapharm.

RegulatoryJune 26, 2026

FDA Approval Update for Morphine Sulfate by Hikma

The FDA has issued an approval letter for the supplemental application of Morphine Sulfate by Hikma.

RegulatoryJune 26, 2026

FDA Approves Supplement for XTAMPZA ER by Collegium Pharma

The FDA has approved a supplemental application for XTAMPZA ER, an extended-release formulation of oxycodone.

RegulatoryJune 26, 2026

FDA Accepts Supplement for Roxicodone by SPECGX LLC

The FDA has accepted a supplemental application for Roxicodone, indicating ongoing regulatory engagement.

RegulatoryJune 26, 2026

FDA Accepts Supplemental NDA for MS CONTIN by KNOA PHARMA

The FDA has accepted a supplemental NDA for MS CONTIN, an opioid pain management medication containing morphine sulfate.

RegulatoryJune 26, 2026

FDA Acceptance of NUCYNTA ER Supplement Application by Collegium Pharma

The FDA has accepted the supplemental application for NUCYNTA ER, indicating a potential update to its labeling or indications.

RegulatoryJune 26, 2026

FDA Accepts Supplemental NDA for Oxycodone Hydrochloride by Genus Lifesciences

The FDA has accepted a supplemental NDA for Oxycodone Hydrochloride submitted by Genus Lifesciences.

RegulatoryJune 26, 2026

FDA Accepts Supplemental Application for Oxycodone Hydrochloride by Genus Lifesciences

The FDA has accepted a supplemental application for Oxycodone Hydrochloride submitted by Genus Lifesciences.

RegulatoryJune 26, 2026

FDA Accepts Supplemental Application for OxyContin by KNOA Pharma

KNOA Pharma's supplemental application for OxyContin has been accepted by the FDA.

RegulatoryJune 26, 2026

FDA Approves Supplemental Application for OXAYDO by ZYLA

The FDA has approved a supplemental application for OXAYDO, an oxycodone hydrochloride product.

RegulatoryJune 26, 2026

FDA Accepts Supplement Application for NUCYNTA (Tapentadol Hydrochloride)

The FDA has accepted a supplemental application for NUCYNTA, an opioid pain medication.

RegulatoryJune 26, 2026

FDA Accepts Supplement for Demerol (Meperidine Hydrochloride)

The FDA has accepted a supplemental application for Demerol, indicating potential updates to its labeling or usage.

RegulatoryJune 26, 2026

FDA Accepts Supplemental NDA for Conzip by Cipher Pharmaceuticals

The FDA has accepted a supplemental NDA for Conzip, which contains tramadol hydrochloride.

RegulatoryJune 26, 2026

FDA Approval of Morphine Sulfate Supplement by Novel Labs

The FDA has approved a supplemental application for Morphine Sulfate submitted by Novel Labs Inc.

RegulatoryJune 26, 2026

FDA Approval for Hydromorphone Hydrochloride Supplement by Actavis Labs

The FDA has approved a supplemental application for Hydromorphone Hydrochloride submitted by Actavis Labs.

RegulatoryJune 26, 2026

FDA Approves Supplement for Morphine Sulfate by Rhodes Pharmaceuticals

The FDA has approved a supplemental application for Morphine Sulfate submitted by Rhodes Pharmaceuticals.

RegulatoryJune 26, 2026

FDA Approval Status for Morphine Sulfate ANDA200812 by Strides Pharma

The FDA has granted approval status (AP) for ANDA200812, a morphine sulfate product from Strides Pharma.

StrategyJune 25, 2026

FDA Approves ANDA for Oxymorphone Hydrochloride by Hikma

The FDA has approved the ANDA for Oxymorphone Hydrochloride submitted by Hikma.

RegulatoryJune 25, 2026

FDA Approval Update for Teva's Tramadol Hydrochloride Supplement

Teva's supplemental application for Tramadol Hydrochloride has received an approval status from the FDA.

RegulatoryJune 25, 2026

FDA Approval Update for Tramadol Hydrochloride by SPECGX LLC

The FDA has granted an approval status for the ANDA075983 application concerning Tramadol Hydrochloride.

RegulatoryJune 25, 2026

FDA Accepts Supplement for Codeine Sulfate by Hikma

The FDA has accepted a supplemental application for Codeine Sulfate submitted by Hikma.

RegulatoryJune 25, 2026

FDA Approves Oxycodone Hydrochloride Supplement by Rhodes Pharmaceuticals

The FDA has approved a supplemental application for Oxycodone Hydrochloride submitted by Rhodes Pharmaceuticals.

RegulatoryJune 25, 2026

FDA Accepts Supplemental Application for Butrans by KNOA Pharma

The FDA has accepted a supplemental application for Butrans, an opioid pain management product containing buprenorphine.

RegulatoryJune 25, 2026

FDA Accepts Supplemental Application for Tapentadol Hydrochloride by Epic Pharma

The FDA has accepted a supplemental application for Tapentadol Hydrochloride submitted by Epic Pharma.

RegulatoryJune 25, 2026

FDA Grants AP Status for Mylan's Fentanyl Supplement

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Mylan's fentanyl supplement.

ClinicalJune 25, 2026

Oliceridine shows potential to reduce PONV in thyroid surgery compared to sufentanil

A study comparing oliceridine to sufentanil in thyroid surgery suggests oliceridine may reduce postoperative nausea and vomiting.

RegulatoryJune 25, 2026

FDA Accepts Supplement Application for BELBUCA (Buprenorphine Hydrochloride)

The FDA has accepted a supplemental application for BELBUCA, an opioid medication.

RegulatoryJune 25, 2026

FDA Approval for Oxycodone Hydrochloride by Novel Labs

The FDA has granted approval for ANDA204021, a supplemental application for Oxycodone Hydrochloride by Novel Labs.

RegulatoryJune 25, 2026

FDA Approves Supplement for Morphine Sulfate by Alkem Labs

The FDA has approved a supplemental application for Morphine Sulfate submitted by Alkem Labs.

RegulatoryJune 25, 2026

FDA Approves Oxycodone Hydrochloride Supplement by Strides Pharma

The FDA has approved a supplemental application for Oxycodone Hydrochloride submitted by Strides Pharma.

RegulatoryJune 24, 2026

FDA Approval for Methadone Hydrochloride by Sun Pharma

The FDA has approved the supplemental application ANDA208305 for Methadone Hydrochloride submitted by Sun Pharma.

RegulatoryJune 24, 2026

FDA Approval Status Update for Hydromorphone Hydrochloride by Osmotica

The FDA has issued an approval status update for ANDA205629 concerning Hydromorphone Hydrochloride.

RegulatoryJune 24, 2026

FDA Accepts Supplement Application for Roxicodone by SPECGX LLC

The FDA has accepted a supplemental application for Roxicodone, indicating ongoing regulatory engagement.

RegulatoryJune 24, 2026

FDA Approves Supplement for Methadone Hydrochloride by Hikma

The FDA has approved a supplemental application for Methadone Hydrochloride submitted by Hikma.

StrategyJune 24, 2026

FDA Grants Approval for Tramadol Hydrochloride ANDA209404 by Macleods

The FDA has granted approval for ANDA209404, a supplemental application for Tramadol Hydrochloride by Macleods Pharmaceuticals.

StrategyJune 24, 2026

Hikma's Roxicet ANDA089351 Receives Abbreviated Approval from FDA

Hikma's Abbreviated New Drug Application (ANDA) for Roxicet has received approval from the FDA.

RegulatoryJune 24, 2026

FDA Accepts Supplemental Application for Oxycodone Hydrochloride

The FDA has accepted a supplemental application for Oxycodone Hydrochloride submitted by Pharm Assoc.

RegulatoryJune 24, 2026

FDA Accepts Supplement for Codeine Sulfate by Hikma

The FDA has accepted a supplemental application for Codeine Sulfate submitted by Hikma.

RegulatoryJune 24, 2026

FDA grants AP status for Fentanyl-75 supplement by Difgen Pharms

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for a supplement of Fentanyl-75 submitted by Difgen Pharmaceuticals.

RegulatoryJune 24, 2026

FDA Approves Supplemental Application for Methadone Hydrochloride by Vistapharm

The FDA has approved a supplemental application for Methadone Hydrochloride submitted by Vistapharm LLC.

RegulatoryJune 24, 2026

FDA Accepts Supplemental NDA for Dilaudid by Rhodes Pharmaceuticals

The FDA has accepted a supplemental NDA for Dilaudid, an opioid pain medication.

RegulatoryJune 24, 2026

FDA Accepts Supplemental NDA for QDOLO by Rosemont

The FDA has accepted a supplemental NDA for QDOLO, a tramadol hydrochloride formulation, submitted by Rosemont.

RegulatoryJune 24, 2026

FDA Accepts Supplemental Application for Tramadol Hydrochloride by Rubicon Research

The FDA has accepted a supplemental application for Tramadol Hydrochloride submitted by Rubicon Research.

RegulatoryJune 24, 2026

FDA Accepts Supplement Application for RoxyBond (NDA209777)

The FDA has accepted a supplemental application for RoxyBond, an oxycodone hydrochloride formulation.

RegulatoryJune 24, 2026

FDA Accepts Supplement Application for Levorphanol Tartrate by Acertis Pharmaceuticals

The FDA has accepted the supplemental application for Levorphanol Tartrate submitted by Acertis Pharmaceuticals.

RegulatoryJune 24, 2026

FDA Approval Status Update for Oxycodone Hydrochloride by Pharmobedient

The FDA has provided an approval status update for ANDA206456, a supplemental application for Oxycodone Hydrochloride submitted by Pharmobedient.

Companies

Assets

Recent signals(104)

FDA Grants AP Status for Meperidine Hydrochloride Supplement

Fresenius Kabi Recalls Morphine Sulfate Injection Due to Labeling Error

FDA Grants Approval for Hydromorphone Hydrochloride ANDA076444

FDA Grants Approval for Methadone Hydrochloride ANDA212093 by Lannett Co Inc

FDA Approves Supplement for Buprenorphine Hydrochloride by Rubicon Research

FDA Grants Approval for Novitium's Tramadol Hydrochloride

FDA Approval Letter for Morphine Sulfate by Fresenius Kabi USA

FDA Approval Status Update for Buprenorphine Hydrochloride by Rubicon Research

FDA Grants Approval for Morphine Sulfate ANDA213892 by Quagen

FDA Approval Status Update for Remifentanil Hydrochloride by Fresenius Kabi

Novitium Pharma's Tramadol Hydrochloride ANDA219647 Receives AP Status

FDA Grants AP Status for Sufentanil Citrate ANDA074534 by Hospira

FDA Approval for Oxycodone Hydrochloride Supplement by Sun Pharma

FDA Approval Status for Methadone Hydrochloride by ThePharmaNetwork LLC

FDA Approves Morphine Sulfate Supplement by Actavis Elizabeth

FDA Acceptance of Supplement for Oxycodone Hydrochloride by Epic Pharma

FDA Approves Supplemental NDA for NUCYNTA (Tapentadol Hydrochloride)

FDA Approves Supplemental Application for Methadone Hydrochloride Intensol by Hikma

FDA Approval for Oxycodone Hydrochloride Supplement by Actavis Elizabeth

Hikma's ANDA090964 for Oxymorphone Hydrochloride Receives AP Status

FDA Approval Status Update for Hydromorphone Hydrochloride by Hikma

FDA Accepts Supplement Application for Oxycodone Hydrochloride by Vistapharm

FDA Approval of Oxycodone Hydrochloride ANDA203823 by Lannett Co Inc

FDA Acceptance of Supplement for Buprenorphine by Watson Labs Teva

FDA Accepts Supplemental Application for Methadone Hydrochloride by Hikma

FDA Approval of Oxymorphone Hydrochloride Supplement by Actavis Elizabeth

FDA Approval Status Update for PERCOCET (ANDA040330)

FDA Accepts Supplement Application for Teva's Morphine Sulfate

FDA Accepts Supplement for XTAMPZA ER by Collegium Pharma

FDA Approval for Morphine Sulfate Supplement by Actavis Elizabeth

FDA Acceptance of Supplemental Application for Oxycodone Hydrochloride

FDA Approval Letter for Oxycodone Hydrochloride ANDA204979

FDA Approval for Morphine Sulfate Supplement by Strides Pharma

FDA Acceptance of Supplemental Application for Hydromorphone Hydrochloride by Hikma

FDA Approves Supplemental Application for Methadone Hydrochloride by Vistapharm

FDA Approval Status Update for Hydrocodone Bitartrate by Alvogen

FDA Accepts Supplement for NUCYNTA ER by Collegium Pharma

FDA Approval Status Update for Hydromorphone Hydrochloride Supplement

FDA Accepts Supplemental NDA for Oxycodone Hydrochloride by Genus Lifesciences

FDA Acceptance of Supplemental NDA for Oxycodone Hydrochloride by Genus Lifesciences

FDA Accepts Supplemental Application for OxyContin by KNOA Pharma

FDA Approval for Morphine Sulfate Supplement by Tris Pharma

FDA Approval Letter for Morphine Sulfate by Upsher Smith Labs

FDA Approves Supplemental NDA for OXAYDO by ZYLA

FDA Approves Supplement for NUCYNTA (Tapentadol Hydrochloride)

Hikma's Tapentadol Hydrochloride ANDA205057 Receives AP Status

FDA Accepts Supplemental Application for Tapentadol Hydrochloride by Novitium Pharma

FDA Approves Supplement for Morphine Sulfate by ANI Pharmaceuticals

FDA Approval for Oxycodone Hydrochloride Supplement by ABHAI LLC

FDA Grants AP Status for Levorphanol Tartrate ANDA213906 by Sun Pharma

FDA Acceptance of Supplement for Codeine Sulfate by Hikma

FDA Approves Supplemental Application for Butrans by KNOA Pharma

FDA Accepts Supplemental NDA for BELBUCA by BDSI

FDA Accepts Supplemental NDA for Percodan by Endo Operations

FDA Acceptance of Supplement for Codeine Sulfate by Hikma

FDA Approves Supplemental Application for Dilaudid by Rhodes Pharmaceuticals

FDA Accepts Supplement for RoxyBond by Protega Pharmaceuticals

FDA Acceptance of Supplement Application for NUCYNTA by Collegium Pharma

FDA Accepts Supplemental NDA for Oxycodone Hydrochloride by Vistapharm

FDA Approval Update for Morphine Sulfate by Hikma

FDA Approves Supplement for XTAMPZA ER by Collegium Pharma

FDA Accepts Supplement for Roxicodone by SPECGX LLC

FDA Accepts Supplemental NDA for MS CONTIN by KNOA PHARMA

FDA Acceptance of NUCYNTA ER Supplement Application by Collegium Pharma

FDA Accepts Supplemental NDA for Oxycodone Hydrochloride by Genus Lifesciences

FDA Accepts Supplemental Application for Oxycodone Hydrochloride by Genus Lifesciences

FDA Accepts Supplemental Application for OxyContin by KNOA Pharma

FDA Approves Supplemental Application for OXAYDO by ZYLA

FDA Accepts Supplement Application for NUCYNTA (Tapentadol Hydrochloride)

FDA Accepts Supplement for Demerol (Meperidine Hydrochloride)

FDA Accepts Supplemental NDA for Conzip by Cipher Pharmaceuticals

FDA Approval of Morphine Sulfate Supplement by Novel Labs

FDA Approval for Hydromorphone Hydrochloride Supplement by Actavis Labs

FDA Approves Supplement for Morphine Sulfate by Rhodes Pharmaceuticals

FDA Approval Status for Morphine Sulfate ANDA200812 by Strides Pharma

FDA Approves ANDA for Oxymorphone Hydrochloride by Hikma

FDA Approval Update for Teva's Tramadol Hydrochloride Supplement