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FDA ANDA · ANDA214065
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Sponsor: ALKEM LABS LTD
APPLICATION
ANDA214065
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-26
LATEST ACTION
2024-12-19
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
2024-12-19Labeling · Supplement 6 · standardAP
2023-05-25Labeling · Supplement 5 · standardAP
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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