Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 078126 for Fosphenytoin Sodium Injection (Now Discontinued)
The FDA approved ANDA 078126 for fosphenytoin sodium injectable in August 2007, issued multiple labeling supplements through 2022, and the product is currently discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Griseofulvin Oral Suspension (ANDA 065394)
The FDA has approved an oral suspension of griseofulvin (125 mg/5 mL) from Actavis Pharma under ANDA 065394.
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Regulatory Updates
Sep 17, 2026•1 min read
FDA Lists Tolazamide 500 mg Oral Tablet (ANDA070169) – Discontinued
The FDA’s ANDA070169 filing for Tolazamide 500 mg oral tablets by USL Pharma is marked as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA063264 for Amikacin Sulfate Injection
The FDA approved ANDA063264 for Amikacin Sulfate injectable by Hospira. The product is listed as discontinued and includes multiple labeling and manufacturing supplemental submissions.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Sanofi Aventis NDA012283 for HYGROTON Chlorthalidone Tablets
The FDA has granted approval (NDA012283) for Sanofi Aventis’s HYGROTON oral tablets containing chlorthalidone 25 mg and 50 mg, previously listed as discontinued but not withdrawn for safety reasons.
Regulatory Updates
Sep 17, 2026•1 min read
FDA NDA012126: 3M's ULO Oral Syrup Discontinued
The FDA records show that 3M's oral syrup product ULO, containing 25 mg/5 mL chlophedianol hydrochloride, is listed as discontinued under application NDA012126.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves HIKMA ANDA062720 for Cephapirin Sodium Injection (Discontinued Products)
The FDA approved HIKMA's ANDA062720 for cephapirin sodium injectable products, all listed as discontinued, with approval dated July 2, 1987.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves NDA011960 for ARISTOCORT Oral Syrup (Triamcinolone Acetate)
The FDA approved NDA011960 for ARISTOCORT oral syrup, a 2 mg/5 mL Triamcinolone Acetate product by Astellas, now listed as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA NDA050306: Discontinued GEOPEN Injectable Carbenicillin Products
The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA071510 for Clorazepate Dipotassium Oral Capsule
The FDA has approved ANDA071510 for a 7.5 mg oral capsule of clorazepate dipotassium, with the product now listed as discontinued and several labeling supplements approved.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Registers Manufacturing Submissions for Discontinued Ibuprofen Tablet (ANDA 071144)
The FDA’s ANDA 071144 records show a discontinued ibuprofen 200 mg oral tablet and a series of approved manufacturing (CMC) and labeling submissions spanning 1987‑1997.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for Discontinued Ibuprofen Tablet
The FDA has approved a series of supplemental applications covering manufacturing and labeling for a discontinued 200 mg oral ibuprofen tablet (product 001).