Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA076316 for Sodium Chloride 0.9% Injection
The FDA has granted approval for ANDA076316, a prescription injectable sodium chloride 0.9% solution in a plastic container, submitted by GVS TM.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Sandoz DRALSERP Tablet (Hydralazine HCl/Reserpine) – ANDA084617
The FDA approved Sandoz's ANDA084617 for the oral tablet DRALSERP containing hydralazine hydrochloride 25 mg and reserpine 0.1 mg; the product is listed as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
CHLORPROMAZINE HYDROCHLORIDE ANDA084113 FDA Approval
FDA approved ANDA084113 for chlorpromazine hydrochloride 50 mg oral tablets, manufactured by Upsher‑Smith Laboratories, LLC.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Manufacturing and Labeling for Propoxyphe ne Hydrochloride 65 mg Oral Capsules
FDA has approved multiple manufacturing (CMC) and labeling submissions for the oral 65 mg Propoxyphe ne Hydrochloride capsule, now listed as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Aminophylline Injection (ANDA081142) by Teva Parenteral
The FDA approved ANDA081142 for an aminophylline injectable product (25 mg/mL) submitted by Teva Parenteral, with original and supplemental approvals in 1991 and 1995.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA078292 for Dronabinol Oral Capsules (Discontinued)
FDA has approved ANDA078292 submitted by Rhodes for oral dronabinol capsules in 10 mg, 5 mg, and 2.5 mg strengths; all products are listed as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA080517 for Prednisolone Sodium Phosphate Injection
FDA approved an ANDA (ANDA080517) for Watson Labs' Prednisolone Sodium Phosphate injectable, originally submitted in 1974; the product is now listed as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA078889 for Metoprolol Succinate Extended‑Release Tablets
The FDA has approved ANDA078889 for generic metoprolol succinate extended‑release tablets (100 mg and 200 mg) from several manufacturers.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA087592)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor Smith and Nephew as discontinued under ANDA087592.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Discontinues FLUONID Topical Ointment (ANDA 087157)
The FDA lists the FLUONID ointment (0.025% fluocinonide) under ANDA 087157 as discontinued, sponsored by Allergan Herbert.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Lists Dextroamphetamine Sulfate Tablet (5 mg) as Discontinued – ANDA 086521
The FDA has marked the oral tablet product Dextroamphetamine Sulfate (5 mg) from sponsor MAST MM as discontinued under ANDA 086521.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA085964 for Acetaminophen and Codeine Phosphate Tablet
The FDA approved ANDA085964 for Sandoz's oral tablet containing 300 mg acetaminophen and 60 mg codeine phosphate; the product is listed as discontinued after multiple labeling submissions.