Zydus Pharmaceuticals — Pharmaceutical Intelligence | Humanexa Signals

RegulatoryAugust 20, 2026

FDA Approval Status Update for Zydus Pharmaceuticals' Spironolactone

Zydus Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Spironolactone under application number ANDA205936.

RegulatoryAugust 18, 2026

FDA Grants Abbreviated Approval for Glipizide and Metformin Hydrochloride

The FDA has granted abbreviated approval for Zydus Pharmaceuticals USA Inc.'s ANDA078905 for Glipizide and Metformin Hydrochloride.

RegulatoryAugust 13, 2026

FDA grants supplemental approval for Zydus' Arsenic Trioxide

The FDA has granted supplemental approval for Zydus Pharmaceuticals' Arsenic Trioxide under application ANDA206228. This approval allows Zydus to market a generic version of Arsenic Trioxide, which is indicated for the treatment of acute promyelocytic leukemia (APL).

RegulatoryAugust 11, 2026

FDA accepts ANDA for Zydus Pharmaceuticals' application 220724

The FDA has accepted the application ANDA220724 from Zydus Pharmaceuticals for review under standard priority. This application is for a generic product, which, upon approval, could introduce competitive pressures in the relevant therapeutic area, affecting existing market players.

RegulatoryAugust 10, 2026

FDA Accepts Supplement for Methotrexate Sodium by Zydus Pharmaceuticals

The FDA has accepted a supplemental application (ANDA207812) for Methotrexate Sodium submitted by Zydus Pharmaceuticals.

RegulatoryAugust 8, 2026

FDA Accepts Supplement Application for Lurasidone Hydrochloride by Zydus Pharms

The FDA has accepted a supplemental application for Lurasidone Hydrochloride submitted by Zydus Pharmaceuticals.

RegulatoryAugust 8, 2026

FDA Submission Overview for Ubrogepant by Zydus Pharmaceuticals

Zydus Pharmaceuticals has submitted an original application for Ubrogepant (ANDA218662) with a standard review priority.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Perphenazine by Zydus Pharmaceuticals

The FDA has an active application (ANDA205232) for Perphenazine submitted by Zydus Pharmaceuticals, currently under review.

RegulatoryJuly 31, 2026

FDA Approval Status Update for Carbamazepine ANDA205571 by Zydus Pharmaceuticals

The FDA has granted an approval status of 'AP' for ANDA205571, a supplemental application for Carbamazepine by Zydus Pharmaceuticals.

RegulatoryJuly 31, 2026

FDA Approves Lenalidomide Supplement by Zydus Pharmaceuticals

The FDA has approved a supplemental application for lenalidomide submitted by Zydus Pharmaceuticals.

RegulatoryJuly 25, 2026

FDA Accepts Supplement Application for Gabapentin by Zydus Pharmaceuticals

The FDA has accepted a supplemental application for gabapentin submitted by Zydus Pharmaceuticals.

RegulatoryJuly 22, 2026

FDA Grants AP Status for Zydus' Arsenic Trioxide ANDA206228

The FDA has granted approval status (AP) for Zydus Pharmaceuticals' Abbreviated New Drug Application for Arsenic Trioxide.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Zydus' Methotrexate Sodium Supplement

The FDA has granted approval status (AP) for Zydus Pharmaceuticals' supplemental application for Methotrexate Sodium.

RegulatoryJuly 13, 2026

FDA Grants AP Status to Zydus' Leuprolide Acetate ANDA215826

The FDA has granted approval status (AP) for Zydus Pharmaceuticals' ANDA215826 for Leuprolide Acetate.

RegulatoryJuly 11, 2026

FDA Grants AP Status for Zydus' Perphenazine Supplement

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for Zydus Pharmaceuticals' supplement for Perphenazine.

RegulatoryJuly 9, 2026

FDA Grants AP Status for Zydus' Glyburide and Metformin Hydrochloride

The FDA has granted approval status (AP) for Zydus Pharmaceuticals' ANDA206748 for Glyburide and Metformin Hydrochloride.

RegulatoryJuly 7, 2026

FDA Accepts Supplement Application for Lenalidomide by Zydus Pharmaceuticals

The FDA has accepted a supplemental application for lenalidomide submitted by Zydus Pharmaceuticals.

RegulatoryJuly 3, 2026

FDA Approval Status Update for Bosentan ANDA207760 by Zydus Pharmaceuticals

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Bosentan submitted by Zydus Pharmaceuticals.

Recent signals(26)

FDA Approval Status Update for Zydus Pharmaceuticals' Spironolactone

FDA Grants Abbreviated Approval for Glipizide and Metformin Hydrochloride

FDA grants supplemental approval for Zydus' Arsenic Trioxide

FDA grants AP status for Zydus' Methylprednisolone ANDA206751

FDA accepts ANDA for Zydus Pharmaceuticals' application 220724

FDA Accepts Supplement for Methotrexate Sodium by Zydus Pharmaceuticals

FDA Accepts Supplement Application for Lurasidone Hydrochloride by Zydus Pharms

FDA Submission Overview for Ubrogepant by Zydus Pharmaceuticals

FDA Grants Approval for Hydrocortisone Sodium Succinate by Zydus Pharmaceuticals

FDA Grants AP Status for Zydus' Linezolid ANDA206097

FDA Approval Process Update for Perphenazine by Zydus Pharmaceuticals

FDA Approval Status Update for Carbamazepine ANDA205571 by Zydus Pharmaceuticals

FDA Approves Lenalidomide Supplement by Zydus Pharmaceuticals

FDA Grants Approval for Zydus' Edaravone ANDA218349

FDA Accepts Supplement Application for Gabapentin by Zydus Pharmaceuticals

FDA Grants AP Status for Zydus' Arsenic Trioxide ANDA206228

FDA Grants AP Status for Zydus' Methylprednisolone ANDA206751

FDA Submission Update for ANDA220724 by Zydus Pharmaceuticals

FDA Grants AP Status for Zydus' Methotrexate Sodium Supplement

FDA Submission for Ubrogepant by Zydus Pharmaceuticals

FDA Grants AP Status to Zydus' Leuprolide Acetate ANDA215826

FDA Grants AP Status for Zydus' Perphenazine Supplement

FDA Grants AP Status for Zydus' Carbamazepine ANDA205571

FDA Grants AP Status for Zydus' Glyburide and Metformin Hydrochloride

FDA Accepts Supplement Application for Lenalidomide by Zydus Pharmaceuticals

FDA Approval Status Update for Bosentan ANDA207760 by Zydus Pharmaceuticals

Upcoming catalysts

Regulatory activity(18)

FDA Approval Status Update for Zydus Pharmaceuticals' Spironolactone

FDA Grants Abbreviated Approval for Glipizide and Metformin Hydrochloride

FDA grants supplemental approval for Zydus' Arsenic Trioxide

FDA accepts ANDA for Zydus Pharmaceuticals' application 220724

FDA Accepts Supplement for Methotrexate Sodium by Zydus Pharmaceuticals

FDA Accepts Supplement Application for Lurasidone Hydrochloride by Zydus Pharms

FDA Submission Overview for Ubrogepant by Zydus Pharmaceuticals

FDA Approval Process Update for Perphenazine by Zydus Pharmaceuticals

FDA Approval Status Update for Carbamazepine ANDA205571 by Zydus Pharmaceuticals

FDA Approves Lenalidomide Supplement by Zydus Pharmaceuticals

FDA Accepts Supplement Application for Gabapentin by Zydus Pharmaceuticals

FDA Grants AP Status for Zydus' Arsenic Trioxide ANDA206228

FDA Grants AP Status for Zydus' Methotrexate Sodium Supplement

FDA Grants AP Status to Zydus' Leuprolide Acetate ANDA215826

FDA Grants AP Status for Zydus' Perphenazine Supplement

FDA Grants AP Status for Zydus' Glyburide and Metformin Hydrochloride

FDA Accepts Supplement Application for Lenalidomide by Zydus Pharmaceuticals

FDA Approval Status Update for Bosentan ANDA207760 by Zydus Pharmaceuticals

Clinical activity

Competitive activity(2)

FDA Grants AP Status for Zydus' Methylprednisolone ANDA206751

FDA Submission Update for ANDA220724 by Zydus Pharmaceuticals

Assets

Therapeutic areas

Indications

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