Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084769
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/10/1976 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
12/16/2016 SUPPL-92 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/04/2001 SUPPL-88 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/2000 SUPPL-87 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2001 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-85 Manufacturing (CMC)-Facility

Label is not available on this site.

05/13/1999 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

05/20/1999 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

11/16/1998 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

04/16/1997 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

08/02/1993 SUPPL-77 Labeling

Label is not available on this site.

04/03/1992 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

05/10/1989 SUPPL-73 Labeling

Label is not available on this site.

07/17/1987 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

07/31/1986 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

07/31/1986 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

07/31/1986 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

07/31/1986 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

03/03/1982 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

10/30/1980 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/13/1977 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 084769 BARR
LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 085475 VALEANT PHARM INTL

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