Hikma — Pharmaceutical Intelligence | Humanexa Signals

RegulatoryAugust 3, 2026

FDA Approval Process Update for Leucovorin Calcium by Hikma

The FDA has an active application (ANDA072733) for Leucovorin Calcium submitted by Hikma, currently under standard review.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Leucovorin Calcium by Hikma

The FDA has an active application for Leucovorin Calcium (ANDA072735) submitted by Hikma, currently under standard review.

RegulatoryAugust 3, 2026

FDA grants approval status for Leucovorin Calcium ANDA072736

The FDA has granted an approval status (AP) for the ANDA072736 application for Leucovorin Calcium submitted by Hikma.

RegulatoryAugust 2, 2026

FDA Approval Status Update for Mycophenolate Mofetil by Hikma

The FDA has issued an approval status update for Hikma's ANDA065410 concerning Mycophenolate Mofetil.

RegulatoryAugust 1, 2026

Hikma's Sugammadex Sodium ANDA218727 Receives Approval Status

Hikma's ANDA for Sugammadex Sodium has received an approval status (AP) from the FDA.

RegulatoryJuly 24, 2026

Hikma's Lisdexamfetamine Dimesylate Supplement Receives FDA Acceptance

The FDA has accepted Hikma's supplemental application for Lisdexamfetamine Dimesylate.

RegulatoryJuly 22, 2026

FDA Accepts Supplement for Diazepam by Hikma

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

RegulatoryJuly 20, 2026

FDA Approves Supplemental Application for Methotrexate Sodium by Hikma

The FDA has approved a supplemental application for Methotrexate Sodium submitted by Hikma.

RegulatoryJuly 18, 2026

Hikma's Lithium Carbonate ANDA Receives Approval Status from FDA

Hikma's application for Lithium Carbonate has received an approval status (AP) from the FDA.

RegulatoryJuly 12, 2026

Hikma's Leucovorin Calcium ANDA072736 Receives AP Status from FDA

Hikma's ANDA for Leucovorin Calcium has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJuly 9, 2026

Hikma's Acetazolamide Sodium ANDA040089 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'Approved' for Hikma's Acetazolamide Sodium.

RegulatoryJune 30, 2026

Hikma's Dipyidamole ANDA074521 Receives AP Status from FDA

Hikma's ANDA074521 for Dipyidamole has received an Abbreviated Approval (AP) status from the FDA.

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 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 Supplemental Application for Methadone Hydrochloride by Hikma

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

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 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 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 Approval Update for Morphine Sulfate by Hikma

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

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 24, 2026

FDA Approves Supplement for Methadone Hydrochloride by Hikma

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

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 23, 2026

FDA Accepts Supplement for Paricalcitol by Hikma Pharmaceuticals

The FDA has accepted a supplemental application for Paricalcitol submitted by Hikma Pharmaceuticals.

Recent signals(38)

FDA Approval Process Update for Leucovorin Calcium by Hikma

FDA Grants Approval for Leucovorin Calcium ANDA072734 by Hikma

FDA Approval Process Update for Leucovorin Calcium by Hikma

FDA grants approval status for Leucovorin Calcium ANDA072736

FDA Approval Status Update for Mycophenolate Mofetil by Hikma

FDA Approval Update for Mycophenolate Mofetil by Hikma

Hikma's Sugammadex Sodium ANDA218727 Receives Approval Status

Hikma's Sugammadex Sodium ANDA218728 Receives Abbreviated Approval

FDA Approval Update for Ciprofloxacin Hydrochloride by Hikma

Hikma's Lisdexamfetamine Dimesylate Supplement Receives FDA Acceptance

FDA Accepts Supplement for Diazepam by Hikma

Hikma's Epinephrine ANDA220562 Receives Abbreviated Approval from FDA

FDA Approves Supplemental Application for Methotrexate Sodium by Hikma

Hikma's Lithium Carbonate ANDA Receives Approval Status from FDA

Hikma's Leucovorin Calcium ANDA072736 Receives AP Status from FDA

Hikma's Leucovorin Calcium ANDA072733 Receives Abbreviated Approval

FDA Grants Approval for Leucovorin Calcium ANDA072734 by Hikma

Hikma's Leucovorin Calcium ANDA072735 Receives Abbreviated Approval

Hikma's Acetazolamide Sodium ANDA040089 Receives AP Status from FDA

Hikma's Levomilnacipran Hydrochloride ANDA210732 Receives AP Status

Hikma's Dipyidamole ANDA074521 Receives AP Status from FDA

FDA Approves Supplemental Application for Methadone Hydrochloride Intensol by Hikma

Hikma's ANDA090964 for Oxymorphone Hydrochloride Receives AP Status

FDA Approval Status Update for Hydromorphone Hydrochloride by Hikma

FDA Accepts Supplemental Application for Methadone Hydrochloride by Hikma

FDA Acceptance of Supplemental Application for Hydromorphone Hydrochloride by Hikma

Hikma's Tapentadol Hydrochloride ANDA205057 Receives AP Status

FDA Acceptance of Supplement for Codeine Sulfate by Hikma

FDA Acceptance of Supplement for Codeine Sulfate by Hikma

FDA Approval Update for Morphine Sulfate by Hikma

FDA Approves ANDA for Oxymorphone Hydrochloride by Hikma

FDA Accepts Supplement for Codeine Sulfate by Hikma

FDA Approves Supplement for Methadone Hydrochloride by Hikma

Hikma's Roxicet ANDA089351 Receives Abbreviated Approval from FDA

FDA Accepts Supplement for Codeine Sulfate by Hikma

Hikma's ANDA for Solriamfetol Hydrochloride Receives Approval Status

FDA Accepts Supplement for Paricalcitol by Hikma Pharmaceuticals

Hikma's Methylprednisolone Sodium Succinate ANDA202691 Receives AP Status

Upcoming catalysts

Regulatory activity(23)

FDA Approval Process Update for Leucovorin Calcium by Hikma

FDA Approval Process Update for Leucovorin Calcium by Hikma

FDA grants approval status for Leucovorin Calcium ANDA072736

FDA Approval Status Update for Mycophenolate Mofetil by Hikma

Hikma's Sugammadex Sodium ANDA218727 Receives Approval Status

Hikma's Lisdexamfetamine Dimesylate Supplement Receives FDA Acceptance

FDA Accepts Supplement for Diazepam by Hikma

FDA Approves Supplemental Application for Methotrexate Sodium by Hikma

Hikma's Lithium Carbonate ANDA Receives Approval Status from FDA

Hikma's Leucovorin Calcium ANDA072736 Receives AP Status from FDA

Hikma's Acetazolamide Sodium ANDA040089 Receives AP Status from FDA

Hikma's Dipyidamole ANDA074521 Receives AP Status from FDA

FDA Approves Supplemental Application for Methadone Hydrochloride Intensol by Hikma

FDA Approval Status Update for Hydromorphone Hydrochloride by Hikma

FDA Accepts Supplemental Application for Methadone Hydrochloride by Hikma

FDA Acceptance of Supplemental Application for Hydromorphone Hydrochloride by Hikma

FDA Acceptance of Supplement for Codeine Sulfate by Hikma

FDA Acceptance of Supplement for Codeine Sulfate by Hikma

FDA Approval Update for Morphine Sulfate by Hikma

FDA Accepts Supplement for Codeine Sulfate by Hikma

FDA Approves Supplement for Methadone Hydrochloride by Hikma

FDA Accepts Supplement for Codeine Sulfate by Hikma

FDA Accepts Supplement for Paricalcitol by Hikma Pharmaceuticals

Clinical activity

Competitive activity(2)

Hikma's Sugammadex Sodium ANDA218728 Receives Abbreviated Approval

Hikma's Methylprednisolone Sodium Succinate ANDA202691 Receives AP Status

Assets

Therapeutic areas

Indications

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