Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084768
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE 5MG 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-89 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/04/2001 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/2000 SUPPL-84 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/23/2000 SUPPL-83 Manufacturing (CMC)-Facility

Label is not available on this site.

12/21/1999 SUPPL-81 Manufacturing (CMC)-Facility

Label is not available on this site.

05/13/1999 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

05/20/1999 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

11/16/1998 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

04/16/1997 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

08/02/1993 SUPPL-74 Labeling

Label is not available on this site.

04/03/1992 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

05/01/1992 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

05/10/1989 SUPPL-69 Labeling

Label is not available on this site.

07/17/1987 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

11/12/1985 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

11/12/1985 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

11/12/1985 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

11/12/1985 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

06/07/1982 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 084768 BARR
LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE 5MG CAPSULE;ORAL Prescription No AB 085461 VALEANT PHARM INTL

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