Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070154
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 10MG TABLET;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
11/01/1985 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
05/29/2003 SUPPL-26 Labeling

Label is not available on this site.

10/25/2001 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

11/19/1999 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

05/07/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/20/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/02/1993 SUPPL-17 Labeling

Label is not available on this site.

04/03/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/04/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/03/1991 SUPPL-11 Labeling

Label is not available on this site.

07/03/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-9 Labeling

Label is not available on this site.

05/02/1988 SUPPL-8 Labeling

Label is not available on this site.

04/01/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/05/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DIAZEPAM

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 070154 BARR
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 071322 IVAX SUB TEVA PHARMS
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 071136 MAYNE PHARMA
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 070325 MYLAN
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription No AB 077749 VINTAGE PHARMS
VALIUM DIAZEPAM 10MG TABLET;ORAL Prescription Yes AB 013263 ROCHE

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