Corticosteroid

StrategyAugust 6, 2026

FDA Grants Approval for Hydrocortisone Sodium Succinate by Zydus Pharmaceuticals

The FDA has granted approval for the ANDA217191 application for Hydrocortisone Sodium Succinate submitted by Zydus Pharmaceuticals.

RegulatoryAugust 5, 2026

FDA Approval Letter for Methylprednisolone Supplement

The FDA has issued an approval letter for a supplement to the ANDA040183 application for Methylprednisolone.

RegulatoryJuly 31, 2026

FDA Approval Process Update for Prednisolone ANDA219509

The FDA is currently processing the ANDA219509 application for Prednisolone submitted by TP ANDA Holdings.

RegulatoryJuly 26, 2026

FDA grants AP status to Methylprednisolone ANDA204072 from Tianjin Tianyao

The FDA has granted approval status (AP) for the ANDA204072 application for Methylprednisolone submitted by Tianjin Tianyao.

StrategyJuly 25, 2026

Fresenius Kabi USA receives AP status for Dexamethasone Sodium Phosphate ANDA209192

Fresenius Kabi USA's ANDA209192 for Dexamethasone Sodium Phosphate has received Abbreviated Approval (AP) status.

StrategyJuly 23, 2026

FDA Grants Approval for Hydrocortisone ANDA218298 by Rising

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Hydrocortisone submitted by Rising.

CompetitiveJuly 22, 2026

FDA Grants AP Status for Zydus' Methylprednisolone ANDA206751

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Zydus Pharmaceuticals' methylprednisolone.

RegulatoryJuly 21, 2026

FDA Grants Approval for Deflazacort ANDA220709 by Carnegie

The FDA has granted approval for the ANDA220709 application for Deflazacort submitted by Carnegie.

RegulatoryJuly 14, 2026

FDA Grants Approval for Hydrocortisone Sodium Succinate by Zydus Pharms

The FDA has granted approval for the ANDA217191 application for Hydrocortisone Sodium Succinate submitted by Zydus Pharms.

StrategyJuly 8, 2026

FDA Grants Approval for Prednisone ANDA218035 by Dr. Reddy's

The FDA has granted approval for Dr. Reddy's Abbreviated New Drug Application for Prednisone.

RegulatoryJuly 7, 2026

FDA Grants AP Status for Prednisolone ANDA219509 by TP ANDA Holdings

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Prednisolone submitted by TP ANDA Holdings.

RegulatoryJuly 1, 2026

FDA Grants AP Status for Methylprednisolone Sodium Succinate by Amneal

The FDA has granted Abbreviated Approval (AP) status for Methylprednisolone Sodium Succinate submitted by Amneal.

RegulatoryJune 19, 2026

FDA Grants AP Status for Methylprednisolone ANDA210985 by Ingenus Pharms

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for methylprednisolone submitted by Ingenus Pharms.

CompetitiveJune 19, 2026

Hikma's Methylprednisolone Sodium Succinate ANDA202691 Receives AP Status

Hikma's application for Methylprednisolone Sodium Succinate (ANDA202691) has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJune 18, 2026

Hikma's Methylprednisolone Sodium Succinate ANDA203125 Receives AP Status

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

RegulatoryJune 8, 2026

FDA Approves Supplement for Methylprednisolone Acetate by Sandoz

The FDA has approved a supplemental application for Methylprednisolone Acetate submitted by Sandoz.

RegulatoryJune 8, 2026

Sandoz's Methylprednisolone ANDA040194 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status to Sandoz for methylprednisolone.

RegulatoryJune 6, 2026

FDA Approves Deflazacort Supplement Application by Upsher Smith Labs

The FDA has approved a supplemental application for Deflazacort submitted by Upsher Smith Labs.

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