Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077165 for Granisetron Hydrochloride Preservative‑Free Injection (DR REDDYS)
The FDA approved ANDA077165 for a preservative‑free granisetron hydrochloride injectable product by Dr. Reddys; the product is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Sandoz ANDA076873 for Metformin Hydrochloride Extended‑Release Tablet
The FDA has approved Sandoz's ANDA076873 for a prescription oral metformin hydrochloride 500 mg extended‑release tablet, with multiple labeling supplements approved.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues Isoniazid Oral Tablet (ANDA083632)
The FDA has listed the 50 mg oral tablet Isoniazid, marketed by Halsey, as discontinued under application ANDA083632.
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
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 NDA007392 for Secobarbital Sodium Injection (Seconal)
FDA has approved NDA007392 for Seconal Sodium injectable, a secobarbital sodium product by Lilly, with a detailed submission history and discontinued marketing status.
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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 Sorbitol 3% Irrigation Solution (NDA017863)
The FDA granted approval for Baxter Healthcare's prescription Sorbitol 3% irrigation solution (NDA017863), a human drug administered via irrigation.
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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.