Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Propoxyphene Compound-65 Oral Capsule
The FDA lists PROPOXYPHENE COMPOUND-65 oral capsules as discontinued, detailing its active ingredients and a series of manufacturing and labeling submissions from 1976 to 1995.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Issues ANDA Approval for Watson Labs' Procaineamide Hydrochloride Oral Capsule (ANDA083795)
The FDA has approved an ANDA (ANDA083795) for Watson Labs' oral capsule containing 250 mg of procaineamide hydrochloride. The product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA080800 for Diphenhydramine Hydrochloride Oral Capsule
FDA granted approval for ANDA080800, a 50 mg diphenhydramine hydrochloride oral capsule submitted by Whiteworth Town Plsn; the product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA 086892 for Chlordiazepoxide Hydrochloride Capsules
The FDA granted approval (ANDA 086892) for Lederle's oral capsule containing 5 mg chlordiazepoxide hydrochloride, listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
Mylan's Chlordiazepoxide Hydrochloride Oral Capsule (ANDA 084887) Discontinued
Mylan's oral capsule product containing 25 mg chlordiazepoxide hydrochloride (product 001) is listed as discontinued. The ANDA includes four manufacturing (CMC) submissions approved on June 10 1981.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues PROVAL #3 Oral Capsule (ANDA085685)
FDA records show PROVAL #3 oral capsule, containing 325 mg acetaminophen and 30 mg codeine phosphate, is now discontinued. Sponsor: Solvay. ANDA085685.
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 ANDA 076251 for Fluoxetine Hydrochloride Capsules (Discontinued)
The FDA has approved ANDA 076251 submitted by Barr for fluoxetine hydrochloride oral capsules, 40 mg base, now listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves RESTORIL (Temazepam) Capsules – NDA018163
The FDA has approved RESTORIL, a prescription oral temazepam capsule from SpecGx LLC, available in 7.5‑30 mg strengths under application NDA018163.
Regulatory Updates
Aug 30, 2026•1 min read
Mylan Discontinues Propoxyphene Hydrochloride 32 mg Oral Capsule (ANDA083528)
Mylan’s ANDA083528 for propoxyphene hydrochloride 32 mg oral capsules is listed as discontinued by the FDA.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Grants Approval for Teva’s Chlordiazepoxide Hydrochloride (ANDA 084768)
The FDA has approved Teva Pharmaceuticals’ oral capsule generic of chlordiazepoxide hydrochloride under ANDA 084768, with multiple supplemental manufacturing and labeling approvals.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 085702 for Phendimetrazine Tartrate Oral Capsule
Sandoz's oral capsule product PHENDIMETRAZINE TARTRATE (35 mg) under application ANDA085702 has received FDA approval; the product is listed as discontinued.