← FDA DRUG APPROVALS

FDA NDA · NDA012750

LIBRAX

chlordiazepoxide hydrochloride and clidinium bromide

Sponsor: BAUSCH

APPLICATION
NDA012750
TYPE
NDA
ORIGINAL APPROVAL
1966-09-01
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

LIBRAX · ReferencePrescription
CHLORDIAZEPOXIDE HYDROCHLORIDE 5MG, CLIDINIUM BROMIDE 2.5MG · CAPSULE · ORAL

Approval history

2023-01-13Labeling · Supplement 68 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 67 · standard — Letter ↗AP
2017-01-13Labeling · Supplement 65 · standard — Label ↗AP
2016-12-16Labeling · Supplement 66 · standard — Letter ↗AP
1966-09-01Type 4 - New Combination · 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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