Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Apotex Nizatidine Capsule ANDA 076383
FDA approved ANDA 076383 for Apotex Inc.'s oral Nizatidine capsules (150 mg and 300 mg) on Jan 23 2003; both products are listed as discontinued.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves ANDA087315 for Hydrocortisone 1% Topical Lotion
The FDA has approved ANDA087315 submitted by Alpharma US Pharms for a 1% hydrocortisone topical lotion, currently listed as discontinued.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 086822)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor SoloPak as discontinued under ANDA 086822.
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Regulatory Updates
Sep 22, 2026•1 min read
FDA Discontinues Chlordiazepoxide Hydrochloride ANDA084700
The FDA has listed the ANDA084700 application for Chlordiazepoxide Hydrochloride 10 mg oral capsules as discontinued. Sponsor Roxane filed the original ANDA in 1976.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Ethosuximide Oral Syrup (ANDA 081306)
The FDA has approved the oral syrup formulation of ethosuximide (250 mg/5 ml) under ANDA 081306, with multiple manufacturing and labeling submissions listed.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 080630 for Cortisone Acetate 25 mg Tablet
The FDA has approved ANDA080630 for a 25 mg oral tablet of cortisone acetate, submitted by IVAX Sub Teva Pharm, with approval dated Jan 3 1972.
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 Lists Discontinued Thioridazine Hydrochloride Tablet (ANDA088660) by West Ward
The FDA database shows an ANDA (ANDA088660) for an oral tablet of thioridazine hydrochloride 25 mg submitted by West Ward, currently marked as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Manufacturing Submission for Mylan’s Thioridazine Hydrochloride Tablet (ANDA088332)
The FDA has approved Mylan’s supplemental application (ANDA088332) for a 10 mg oral tablet of thioridazine hydrochloride, though 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 22, 2026•1 min read
FDA Approves ANDA 078338 for Clotrimazole 1% Topical Cream
The FDA has approved ANDA 078338 for a prescription 1% clotrimazole topical cream marketed by Fougera Pharmas.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA078039 for Meloxicam Oral Tablets (7.5 mg & 15 mg)
The FDA has granted approval for ANDA078039 submitted by CR DOUBLE CRANE for meloxicam oral tablets in 7.5 mg and 15 mg strengths. Both products are listed as discontinued.