Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA081008 for STRIFON FORTE DSC (Chlorzoxazone)
FDA approved labeling and manufacturing submissions for ANDA081008 covering the oral tablet STRIFON FORTE DSC (500 mg chlorzoxazone) by Fern Dale Labs; the product is now discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Manufacturing and Labeling Submissions for Discontinued Chlorpromazine Tablets
FDA has approved multiple manufacturing and labeling submissions for discontinued chlorpromazine hydrochloride tablets, noting the discontinuations were not due to safety or effectiveness concerns.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Testosterone Injectable (Product 001) – Submission History
The FDA has marked the testosterone injectable (product 001) as discontinued, with a record of multiple labeling and manufacturing submissions dating back to 1983.
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 ANDA077652 for Levofloxacin Oral Tablets
The FDA has approved ANDA077652 for levofloxacin tablets (250 mg, 500 mg, 750 mg) manufactured by Zydus Lifesciences and Viona Pharmaceuticals.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077345 for Sertraline Hydrochloride Tablets (Heritage Pharma Avet)
The FDA has approved ANDA077345 submitted by Heritage Pharma Avet for oral sertraline hydrochloride tablets in 25 mg, 50 mg and 100 mg strengths. All listed products are currently marked discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling Submissions for Loxapine Succinate (ANDA076762)
FDA has approved several labeling supplements for the discontinued oral capsule products of Loxapine Succinate under ANDA076762.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Mometasone Furoate Topical Ointment (ANDA076481)
FDA granted approval for ANDA076481, a prescription 0.1% mometasone furoate topical ointment manufactured by Encube Ethicals, Inc.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling for PLASMA‑LYTE 56 and Dextrose 5% Injection (NDA 017385)
The FDA approved labeling for the discontinued injectable PLASMA‑LYTE 56 and Dextrose 5% product, with multiple manufacturing submissions approved since 1986.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Lupin Losartan Potassium/Hydrochlorothiazide Combination (ANDA078245)
FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.
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 Issues ANDA084080 for Promethazine Hydrochloride Tablet
FDA assigned ANDA084080 to TABLICAPS for an oral 12.5 mg promethazine hydrochloride tablet, now listed as discontinued.