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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085472
Company: BAUSCH

Products on ANDA 085472

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085472

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/1977	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-50	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/05/2021	SUPPL-48	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-47	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/26/2002	SUPPL-43	Labeling		Label is not available on this site.
09/26/2002	SUPPL-42	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/26/2002	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
09/26/2002	SUPPL-40	Manufacturing (CMC)-Facility		Label is not available on this site.
10/20/1997	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
11/28/1997	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
11/03/1994	SUPPL-37	Labeling		Label is not available on this site.
03/27/1991	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
02/06/1989	SUPPL-35	Labeling		Label is not available on this site.
04/01/1988	SUPPL-33	Labeling		Label is not available on this site.
11/02/1987	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
06/07/1984	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
06/09/1983	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
07/14/1982	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
05/14/1982	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
03/30/1982	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 085472

LIBRIUM

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	Yes	AB	083116	BARR
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	084041	CHARTWELL RX
LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	Yes	AB	085472	BAUSCH

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