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FDA ANDA · ANDA211421
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Sponsor: NUVO PHARMS INC
APPLICATION
ANDA211421
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-07
LATEST ACTION
2022-08-24
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
2022-08-24Labeling · Supplement 2 · 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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