Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
#chlordiazepoxide ×
Regulatorische Updates
22. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
22. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA088010 for Chlordiazepoxide Hydrochloride Capsule
FDA granted approval (status AP) for VANGARD's ANDA088010 covering a 10 mg oral capsule of chlordiazepoxide hydrochloride, listed as discontinued.
Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
9. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
9. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
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.