Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071321
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 5MG 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
12/10/1986 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
03/09/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

01/28/2013 SUPPL-31 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/23/2008 SUPPL-26 Labeling

Label is not available on this site.

07/29/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

03/27/2002 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

03/30/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/29/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/30/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-6 Labeling

Label is not available on this site.

07/25/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/14/1990 SUPPL-4 Labeling

Label is not available on this site.

03/14/1990 SUPPL-3 Labeling

Label is not available on this site.

03/25/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DIAZEPAM

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Prescription No AB 071321 IVAX SUB TEVA PHARMS
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Prescription No AB 071135 MAYNE PHARMA
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Prescription No AB 070325 MYLAN
DIAZEPAM DIAZEPAM 5MG TABLET;ORAL Prescription No AB 077749 VINTAGE PHARMS
VALIUM DIAZEPAM 5MG TABLET;ORAL Prescription Yes AB 013263 ROCHE

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