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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070706
Company: ACTAVIS ELIZABETH
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
03/19/1986 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
11/20/2003 SUPPL-14 Labeling

Label is not available on this site.

10/11/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

10/25/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/18/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-5 Labeling

Label is not available on this site.

10/06/1988 SUPPL-4 Labeling

Label is not available on this site.

06/07/1988 SUPPL-3 Labeling

Label is not available on this site.

01/21/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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