Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves HIKMA Ciprofloxacin Injection (ANDA078431)
FDA granted labeling approval for HIKMA Farmaceutica's ciprofloxacin 400 mg/200 mL injection under ANDA078431, with multiple supplemental approvals since 2009.
Regulatory Updates
Sep 23, 2026•1 min read
Roche’s ENDEP (Amitriptyline HCl 150mg) ANDA085303 Approved; product now discontinued
The FDA approved Roche’s ANDA085303 for ENDEP, an oral 150 mg amitriptyline hydrochloride tablet. The product is currently listed as discontinued.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Labeling Supplements for Discontinued Divalproex Sodium Delayed‑Release Tablets
The FDA records show that three discontinued oral delayed‑release tablet products of Divalproex Sodium (125 mg, 250 mg, 500 mg) received approved labeling supplemental submissions.
Regulatory Updates
Sep 22, 2026•1 min read
Quantum Pharmics ANDA 088972 – Oral Tablet with Butalbital, Aspirin
Quantum Pharmics filed ANDA 088972 for an oral tablet combining 50 mg butalbital, 325 mg aspirin, and 40 mg caffeine; the product is listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA088010 for Chlordiazepoxide Hydrochloride Capsule
FDA granted approval (status AP) for VANGARD's ANDA088010 covering a 10 mg oral capsule of chlordiazepoxide hydrochloride, listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Accepts ANDA084026 for Watson Labs' Chlorothiazide 500 mg Oral Tablet (Discontinued)
The FDA has processed application ANDA084026 for Watson Labs' oral chlorothiazide 500 mg tablet, currently listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Alembic’s Generic Lithium Carbonate Capsules (ANDA 079159)
The FDA has granted approval for Alembic Pharmaceuticals’ generic lithium carbonate oral capsules in 150 mg, 300 mg, and 600 mg strengths under ANDA 079159.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA085911 for Oxycodone 5/APAP 500 Oral Tablet
FDA approved ANDA085911 for an oral tablet containing 5 mg oxycodone and 500 mg acetaminophen, submitted by Bristol Myers Squibb; the product is listed as 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 19, 2026•1 min read
FDA Approves ANDA083442 for Meprobamate 400mg Oral Tablet
The FDA approved ANDA083442 for a 400 mg oral tablet of meprobamate submitted by Whiteworth Town Plsn; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA088262 for Imipramine Hydrochloride Tablets by Strides Pharma
The FDA has approved the ANDA for Imipramine Hydrochloride 25 mg oral tablets (brand name IMIPRAMINE HYDROCHLORIDE) manufactured by Strides Pharma Science Limited, with the latest labeling approval on May 1 2023.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA077222 for Fosinopril Sodium Tablets
The FDA has approved ANDA077222 for generic fosinopril sodium oral tablets in 10 mg, 20 mg, and 40 mg strengths, sponsored by Invagen Pharms.