Regulatory Updates
Sep 15, 2026•1 min read
Sandoz Receives FDA Tentative Approval for Epinastine Hydrochloride Ophthalmic Solution (ANDA090950)
Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Multiple Potassium Chloride Injection Products (ANDA080195)
The FDA’s ANDA080195 filing shows that MILES’ injectable potassium chloride products (1–4 mEq/mL) are listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Lists ANDA083706 for Mylan Propantheline Bromide 15 mg Tablet
FDA records an ANDA (ANDA083706) for Mylan's oral propantheline bromide 15 mg tablet, currently marked as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves BEL MAR Testosterone Propionate Injection (ANDA080741)
The FDA approved ANDA080741 for BEL MAR's Testosterone Propionate injectable, a discontinued product, on Dec 3, 1973.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Sandoz Children’s Cetirizine Hydrochloride Chewable Tablets (ANDA 078692)
The FDA has approved Sandoz’s over‑the‑counter children’s cetirizine hydrochloride chewable tablets (5 mg and 10 mg) under ANDA 078692.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA078102 for Meloxicam Oral Tablets
FDA approved application ANDA078102 submitted by TARO for meloxicam tablets (7.5 mg and 15 mg). Both products are listed with discontinued marketing status.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Tentative Approval for Reddys Escitalopram Oxalate Tablets
The FDA granted a Tentative Approval for Dr Reddys Labs' ANDA 077798, covering oral tablets of Escitalopram Oxalate in 5 mg, 10 mg, and 20 mg strengths.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Supplemental Submissions for Amitriptyline Hydrochloride Tablet (ANDA 085742)
The FDA has approved a series of supplemental submissions for the oral tablet Amitriptyline Hydrochloride (product 002), originally approved in 1977, now listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Teva's Chlordiazepoxide Hydrochloride Generic (ANDA 084769)
The FDA has approved Teva Pharmaceuticals' generic chlordiazepoxide hydrochloride oral capsules (ANDA 084769) with 25 mg strength and multiple NDC codes.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA086148 for Amitriptyline Hydrochloride 150 mg Oral Tablet
The FDA has approved application ANDA086148 submitted by Roxane for a 150 mg oral tablet of amitriptyline hydrochloride, now listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Bausch & Lomb OFLOXACIN Ophthalmic Solution (ANDA 076622)
The FDA granted approval for Bausch & Lomb's OFLOXACIN 0.3% ophthalmic solution (prescription) under ANDA 076622, originally approved in May 2004 with a labeling update in 2020.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA 085231 for Pyrilamine Maleate Oral Tablet by Watson Labs
The FDA granted approval for ANDA 085231, an oral tablet containing 25 mg pyrilamine maleate, submitted by Watson Labs. The product is listed as discontinued.