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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071136
Company: MAYNE PHARMA
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
02/03/1987 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
08/02/2021 SUPPL-39 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/02/2021 SUPPL-36 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/09/2015 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

08/06/2008 SUPPL-25 Labeling

Label is not available on this site.

04/25/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-11 Labeling

Label is not available on this site.

01/28/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/18/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/18/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/18/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/04/1988 SUPPL-4 Labeling

Label is not available on this site.

08/11/1988 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 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 STRIDES PHARMA
VALIUM DIAZEPAM 10MG TABLET;ORAL Prescription Yes AB 013263 WAYLIS THERAP
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