Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070153
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Discontinued None 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.

01/29/2001 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

12/21/1999 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.

08/02/1993 SUPPL-18 Labeling

Label is not available on this site.

04/03/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/03/1991 SUPPL-14 Labeling

Label is not available on this site.

07/03/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-12 Labeling

Label is not available on this site.

09/08/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/08/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/01/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/14/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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