Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083116
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE 10MG 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-109 Labeling-Package Insert

Label is not available on this site.

12/04/2001 SUPPL-104 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/2000 SUPPL-103 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2001 SUPPL-102 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-101 Manufacturing (CMC)-Facility

Label is not available on this site.

05/13/1999 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

05/20/1999 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

11/16/1998 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

04/16/1997 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

08/02/1993 SUPPL-94 Labeling

Label is not available on this site.

04/03/1992 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

05/01/1989 SUPPL-90 Labeling

Label is not available on this site.

07/17/1987 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

11/19/1985 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

11/19/1985 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

11/19/1985 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

11/19/1985 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

11/19/1985 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

03/29/1982 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

CHLORDIAZEPOXIDE HYDROCHLORIDE

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 No AB 083116 BARR
LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 085472 VALEANT PHARM INTL

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