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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071135
Company: MAYNE PHARMA
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
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-38 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/02/2021 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/09/2015 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

08/06/2008 SUPPL-24 Labeling

Label is not available on this site.

04/25/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-10 Labeling

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.

07/10/1990 SUPPL-6 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; 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 STRIDES PHARMA
VALIUM DIAZEPAM 5MG TABLET;ORAL Prescription Yes AB 013263 WAYLIS THERAP
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