Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Bionpharma’s Nicardipine Hydrochloride Capsules (ANDA217555)
The FDA granted approval (AP) for Bionpharma Inc.’s nicardipine hydrochloride oral capsules, 20 mg and 30 mg strengths, under application ANDA217555.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Discontinues Chlordiazepoxide Hydrochloride ANDA084700
The FDA has listed the ANDA084700 application for Chlordiazepoxide Hydrochloride 10 mg oral capsules as discontinued. Sponsor Roxane filed the original ANDA in 1976.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Issues Tentative Approval for Atomoxetine Hydrochloride Capsules (ANDA078940)
The FDA has granted tentative approval for six oral capsule strengths of atomoxetine hydrochloride under ANDA078940, sponsored by Actavis Elizabeth.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Alembic’s Generic Lithium Carbonate Capsules (ANDA 079159)
The FDA has granted approval for Alembic Pharmaceuticals’ generic lithium carbonate oral capsules in 150 mg, 300 mg, and 600 mg strengths under ANDA 079159.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Apotex Generic Tizanidine Hydrochloride Capsules (ANDA078868)
The FDA has approved Apotex’s generic Tizanidine Hydrochloride oral capsules (2 mg, 4 mg, 6 mg) under application ANDA078868.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 076648 for Nitrofurantoin Oral Capsules (Monohydrate/Macrocrystals)
The FDA granted approval for ANDA 076648, covering nitrofurantoin (75 mg + 25 mg macrocrystalline) oral capsules marketed by Chartwell Rx.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA084731 for Theophylline Oral Capsules (Discontinued)
The FDA has approved ANDA084731 for Theophylline capsules in 100 mg, 200 mg and 250 mg strengths. All three products are listed as discontinued by sponsor Scherer RP.
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
Aug 30, 2026•1 min read
FDA Approves Hikma Dronabinol Oral Capsules (ANDA 079217)
FDA approved Hikma's ANDA 079217 for oral Dronabinol capsules (2.5 mg, 5 mg, 10 mg); all listed products are currently marked discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Multiple Supplemental Submissions for Procaineamide Hydrochloride Capsules (Discontinued)
The FDA has approved several supplemental labeling and manufacturing submissions for the oral capsule product Procaineamide Hydrochloride, which is currently listed as discontinued.
Regulatory Updates
Aug 29, 2026•1 min read
FDA Approves ANDA083089 for Propoxyphene Hydrochloride Capsules (Roxane)
FDA granted approval for ANDA083089 covering two oral capsule strengths of propoxyphene hydrochloride by Roxane; both products are listed as discontinued.