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FDA ANDA · ANDA215555

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Sponsor: AMNEAL

APPLICATION
ANDA215555
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-25
LATEST ACTION
2023-07-21
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

2023-07-21Labeling · Supplement 2 · standardAP
2022-12-23Labeling · Supplement 1 · standardAP
2021-10-25UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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.

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