← FDA DRUG APPROVALS

FDA ANDA · ANDA216969

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Sponsor: ALEMBIC

APPLICATION
ANDA216969
TYPE
ANDA
ORIGINAL APPROVAL
2023-09-15
LATEST ACTION
2023-09-15
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

2023-09-15UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →