Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070325
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 10MG TABLET;ORAL Prescription AB No No
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription AB No No
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
09/04/1985 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
11/25/2008 SUPPL-19 Labeling

Label is not available on this site.

12/19/2002 SUPPL-12 Labeling

Label is not available on this site.

02/25/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/30/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/14/1993 SUPPL-7 Labeling

Label is not available on this site.

06/19/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/29/1989 SUPPL-4 Labeling

Label is not available on this site.

02/03/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/08/1986 SUPPL-2 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

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 070152 BARR
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 071307 IVAX SUB TEVA PHARMS
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 071134 MAYNE PHARMA
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 070325 MYLAN
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 077749 VINTAGE PHARMS
VALIUM DIAZEPAM 2MG TABLET;ORAL Prescription Yes AB 013263 ROCHE

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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