← FDA DRUG APPROVALS

FDA ANDA · ANDA214698

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Sponsor: DR REDDYS

APPLICATION
ANDA214698
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-10
LATEST ACTION
2023-04-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEPrescription
CHLORDIAZEPOXIDE HYDROCHLORIDE 5MG, CLIDINIUM BROMIDE 2.5MG · CAPSULE · ORAL

Approval history

2023-04-19Labeling · Supplement 2 · standardAP
2021-05-10UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →