Regulatory Updates
Sep 15, 2026•1 min read
Epic Pharma receives FDA approval for Tizanidine Hydrochloride tablets (ANDA076347)
Epic Pharma LLC's ANDA076347 for prescription oral tablets of Tizanidine Hydrochloride (2 mg and 4 mg) has been approved by the FDA, with labeling submissions approved between 2007 and 2016.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA077510 for Colestipol Hydrochloride Tablets
The FDA has approved ANDA077510 for Colestipol Hydrochloride 1 g tablets, manufactured by Amneal Pharmaceuticals and sponsored by IMPAX Labs.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ZADITOR Ophthalmic OTC Solution (ANDA077200)
FDA has approved ZADITOR, an over‑the‑counter ophthalmic solution containing 0.025% ketotifen fumarate (application ANDA077200).
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Labeling Supplements for MirtaZAPINE (ANDA 076901)
FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA 084640 for DIPHEN Oral Elixir (USL Pharma)
FDA's ANDA 084640 for DIPHEN oral elixir, containing diphenhydramine hydrochloride 12.5 mg/5 mL, was approved for USL Pharma with multiple manufacturing supplements; the product is now discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Lists Diphenhydramine Hydrochloride Injection (ANDA083533) as Discontinued
Watson Labs' diphenhydramine hydrochloride injectable (product 001) is recorded by the FDA under ANDA083533 as discontinued and not a reference drug.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA081213 for ESTROPIPATE Oral Tablet
The FDA has granted approval (ANDA081213) for Watson Labs' ESTROPIPATE 0.75 mg oral tablet, with several labeling and manufacturing submissions approved.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA089706 for Hydrocortisone 1% Cream – Discontinued
The FDA approved ANDA089706 for a topical hydrocortisone 1% cream submitted by NASKA. The product is listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Lists ANDA089313 for Chorionic Gonadotropin Injection (Discontinued)
The FDA’s ANDA089313 for CHORIONIC GONADOTROPIN injection by Quad Pharm is listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA084144 for Proparacaine Hydrochloride Ophthalmic Solution
The FDA approved ANDA084144 for a 0.5% proparacaine hydrochloride ophthalmic solution (drops) submitted by SOLA BARNES HIND; the product is now discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Reserpine and Hydroflumethiazide Tablet (ANDA 088932)
The FDA granted approval (AP) for ANDA 088932 submitted by IVAX PHARMS for an oral tablet containing 0.125 mg reserpine and 50 mg hydroflumethiazide; the product is listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Lists TEVA's TRIPHED Oral Tablet as Discontinued (ANDA088630)
The FDA record for ANDA088630 shows TEVA's TRIPHED oral tablet, containing pseudoephedrine HCl 60 mg and triprolidine HCl 2.5 mg, is now marked discontinued.