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Company

Amneal Pharmaceuticals

Pharmaceutical intelligence for Amneal Pharmaceuticals with 22 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
13
Catalysts
9
Assets
9

Recent signals(13)

RegulatoryAugust 5, 2026

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Amneal Pharmaceuticals

The FDA has granted abbreviated approval for Metformin Hydrochloride under application ANDA078596 submitted by Amneal Pharmaceuticals.

RegulatoryAugust 5, 2026

FDA Grants Approval Status for Capecitabine ANDA204741 by Amneal Pharmaceuticals

The FDA has granted an approval status of 'AP' for Amneal Pharmaceuticals' ANDA204741 for Capecitabine.

RegulatoryJuly 29, 2026

FDA Accepts Supplement for Metformin Hydrochloride by Amneal Pharmaceuticals

The FDA has accepted a supplemental application for Metformin Hydrochloride from Amneal Pharmaceuticals.

StrategyJuly 26, 2026

FDA Grants AP Status for Milnacipran Hydrochloride by Amneal Pharmaceuticals

The FDA has granted Abbreviated Approval (AP) status for Milnacipran Hydrochloride submitted by Amneal Pharmaceuticals.

RegulatoryJuly 20, 2026

Amneal Pharmaceuticals Receives AP Status for Methotrexate Sodium ANDA210040

Amneal Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Methotrexate Sodium.

RegulatoryJuly 19, 2026

FDA Grants Supplement Approval for Lurasidone Hydrochloride by Amneal Pharmaceuticals

The FDA has granted approval for a supplemental application for Lurasidone Hydrochloride submitted by Amneal Pharmaceuticals.

RegulatoryJuly 15, 2026

FDA Approval Update for Methylergomovine Maleate by Amneal Pharmaceuticals

The FDA has accepted the supplemental application ANDA211483 for Methylergonovine Maleate submitted by Amneal Pharmaceuticals.

CompetitiveJuly 13, 2026

Amneal Pharmaceuticals submits supplemental ANDA for Capecitabine

Amneal Pharmaceuticals has submitted a supplemental abbreviated new drug application (ANDA) for Capecitabine.

RegulatoryJuly 3, 2026

Amneal Pharmaceuticals submits ANDA for Milnacipran Hydrochloride

Amneal Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) for Milnacipran Hydrochloride.

RegulatoryJune 29, 2026

FDA Approval Update for Hydrocodone Bitartrate and Ibuprofen by Amneal Pharmaceuticals

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for a combination of hydrocodone bitartrate and ibuprofen by Amneal Pharmaceuticals.

StrategyJune 25, 2026

FDA Approval Letter for Hydrocodone Bitartrate and Acetaminophen

The FDA has issued an approval letter for ANDA207137, a combination of hydrocodone bitartrate and acetaminophen.

RegulatoryJune 25, 2026

FDA Approval for Amneal's Tramadol Hydrochloride Supplement

The FDA has granted approval for Amneal Pharmaceuticals' supplemental application for Tramadol Hydrochloride.

StrategyJune 24, 2026

FDA Approval Letter for Hydrocodone Bitartrate and Acetaminophen

The FDA has issued an approval letter for ANDA206869, a combination of hydrocodone bitartrate and acetaminophen.

Upcoming catalysts

No catalysts indexed for this entity yet.

Regulatory activity(9)

RegulatoryAugust 5, 2026

FDA Grants Abbreviated Approval for Metformin Hydrochloride by Amneal Pharmaceuticals

The FDA has granted abbreviated approval for Metformin Hydrochloride under application ANDA078596 submitted by Amneal Pharmaceuticals.

RegulatoryAugust 5, 2026

FDA Grants Approval Status for Capecitabine ANDA204741 by Amneal Pharmaceuticals

The FDA has granted an approval status of 'AP' for Amneal Pharmaceuticals' ANDA204741 for Capecitabine.

RegulatoryJuly 29, 2026

FDA Accepts Supplement for Metformin Hydrochloride by Amneal Pharmaceuticals

The FDA has accepted a supplemental application for Metformin Hydrochloride from Amneal Pharmaceuticals.

RegulatoryJuly 20, 2026

Amneal Pharmaceuticals Receives AP Status for Methotrexate Sodium ANDA210040

Amneal Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Methotrexate Sodium.

RegulatoryJuly 19, 2026

FDA Grants Supplement Approval for Lurasidone Hydrochloride by Amneal Pharmaceuticals

The FDA has granted approval for a supplemental application for Lurasidone Hydrochloride submitted by Amneal Pharmaceuticals.

RegulatoryJuly 15, 2026

FDA Approval Update for Methylergomovine Maleate by Amneal Pharmaceuticals

The FDA has accepted the supplemental application ANDA211483 for Methylergonovine Maleate submitted by Amneal Pharmaceuticals.

RegulatoryJuly 3, 2026

Amneal Pharmaceuticals submits ANDA for Milnacipran Hydrochloride

Amneal Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) for Milnacipran Hydrochloride.

RegulatoryJune 29, 2026

FDA Approval Update for Hydrocodone Bitartrate and Ibuprofen by Amneal Pharmaceuticals

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for a combination of hydrocodone bitartrate and ibuprofen by Amneal Pharmaceuticals.

RegulatoryJune 25, 2026

FDA Approval for Amneal's Tramadol Hydrochloride Supplement

The FDA has granted approval for Amneal Pharmaceuticals' supplemental application for Tramadol Hydrochloride.

Clinical activity

No signals indexed for this entity yet.

Competitive activity(1)

CompetitiveJuly 13, 2026

Amneal Pharmaceuticals submits supplemental ANDA for Capecitabine

Amneal Pharmaceuticals has submitted a supplemental abbreviated new drug application (ANDA) for Capecitabine.

Assets

Amneal →
Capecitabine →
FDA →
Lurasidone Hydrochloride →
Methotrexate Sodium →
Methylergonovine Maleate →
Milnacipran Hydrochloride →
Regulatory Approval →
Tramadol Hydrochloride →

Therapeutic areas

Analgesic →
Antipsychotic →
Chemotherapy →
Diabetes →
Neurology →
Neurology · Pain Management →
Obstetrics →
Obstetrics · Uterotonics →
Oncology →
Oncology · Chemotherapy →
Opioid Combination →
Oral Hypoglycemic →
Pain Management →
Pain Management · Analgesic →
Pain Management · Opioid Combination →
Psychiatry →
Psychiatry · Antipsychotic →
Uterotonics →

Indications

Diabetes →

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