Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 077780 for Carvedilol Tablets by TARO
FDA issued an approval letter for ANDA 077780 covering carvedilol oral tablets (3.125 mg, 6.25 mg, 12.5 mg, 25 mg) submitted by TARO; all listed products are marked discontinued.
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Regulatory Updates
Sep 24, 2026•1 min read
DIPHENHYDRAMINE HYDROCHLORIDE
FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA084581 for Hydralazine Tablet – IVAX Sub Teva
FDA approved ANDA084581 for a 100 mg oral tablet of Hydralazine Hydrochloride by IVAX Sub Teva Pharm on Sep 12 1975; the product is now discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA077826 for Fenoldopam Mesylate Injection
The FDA has approved an Abbreviated New Drug Application (ANDA077826) for fenoldopam mesylate injection submitted by Teva Parenteral.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves AUVELITY Extended-Release Tablet (NDA 215430)
The FDA has approved AUVELITY, an oral extended‑release tablet combining bupropion hydrochloride and dextromethorphan hydrobromide under NDA 215430.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Priority Approval to EPIZYME’s Orphan Drug TAZVERIK (TAZEMETOSTAT HYDROBROMIDE 200 mg)
The FDA approved TAZVERIK, a prescription oral tablet for EPIZYME Inc., under NDA 213400 with priority review and orphan designation.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Alembic’s Tretinoin 0.05% Topical Cream (ANDA214590)
The FDA has granted approval for Alembic’s prescription tretinoin 0.05% cream, submitted under ANDA214590.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Mylan Generic Levetiracetam Tablets (ANDA 076919)
The FDA has approved Mylan Pharmaceuticals' generic levetiracetam tablets (250 mg, 500 mg, 750 mg) under ANDA 076919.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ARGATROBAN Injection (ANDA091665)
The FDA has approved ANDA091665 for ARGATROBAN injection, a prescription anticoagulant submitted by PH HEALTH.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA 076235 for Carboplatin Injection (Fresenius Kabi USA)
The FDA approved ANDA 076235 for carboplatin injectable products submitted by Fresenius Kabi USA on Oct 14, 2004. All listed strengths are currently discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves OSTEOSCAN (NDA 017454) as Radiopharmaceutical Injection
FDA granted priority approval to OSTEOSCAN, a technetium‑99m etidronate injectable, on Sep 28 1973; later supplemental filings updated labeling, manufacturing and efficacy. Product now discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves NDA017421 for DIAL Topical Solution Containing 0.25% Hexachlorophene
The FDA granted approval (NDA017421) for DIAL’s discontinued topical solution containing 0.25% hexachlorophene.