Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089685
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERPHENAZINE PERPHENAZINE 8MG TABLET;ORAL Prescription AB No No
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription AB No No
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription AB No No
PERPHENAZINE PERPHENAZINE 16MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/08/1988 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
02/23/2017 SUPPL-27 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/06/2010 SUPPL-24 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/089683s024lbl.pdf
05/27/2009 SUPPL-22 Labeling

Label is not available on this site.

11/25/2008 SUPPL-21 Labeling

Label is not available on this site.

11/19/2008 SUPPL-20 Labeling

Label is not available on this site.

05/29/2008 SUPPL-15 Labeling

Label is not available on this site.

10/22/2002 SUPPL-13 Labeling

Label is not available on this site.

10/22/2002 SUPPL-12 Labeling

Label is not available on this site.

05/15/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/15/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/15/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/16/1998 SUPPL-5 Labeling

Label is not available on this site.

10/16/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/07/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-2 Labeling

Label is not available on this site.

10/01/1990 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/06/2010 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/089683s024lbl.pdf

PERPHENAZINE

TABLET;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PERPHENAZINE PERPHENAZINE 8MG TABLET;ORAL Prescription No AB 206691 MYLAN
PERPHENAZINE PERPHENAZINE 8MG TABLET;ORAL Prescription No AB 205056 RISING
PERPHENAZINE PERPHENAZINE 8MG TABLET;ORAL Prescription No AB 089685 SANDOZ
PERPHENAZINE PERPHENAZINE 8MG TABLET;ORAL Prescription No AB 040226 VINTAGE PHARMS
PERPHENAZINE PERPHENAZINE 8MG TABLET;ORAL Prescription No AB 207582 WATSON LABS INC
PERPHENAZINE PERPHENAZINE 8MG TABLET;ORAL Prescription No AB 205973 WILSHIRE PHARMS INC

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription No AB 206691 MYLAN
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription No AB 205056 RISING
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription No AB 089683 SANDOZ
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription No AB 089685 SANDOZ
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription No AB 040226 VINTAGE PHARMS
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription No AB 207582 WATSON LABS INC
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription No AB 205973 WILSHIRE PHARMS INC

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription No AB 206691 MYLAN
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription No AB 205056 RISING
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription No AB 089684 SANDOZ
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription No AB 089685 SANDOZ
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription No AB 040226 VINTAGE PHARMS
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription No AB 207582 WATSON LABS INC
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription No AB 205973 WILSHIRE PHARMS INC

TABLET;ORAL; 16MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PERPHENAZINE PERPHENAZINE 16MG TABLET;ORAL Prescription No AB 206691 MYLAN
PERPHENAZINE PERPHENAZINE 16MG TABLET;ORAL Prescription No AB 205056 RISING
PERPHENAZINE PERPHENAZINE 16MG TABLET;ORAL Prescription No AB 089685 SANDOZ
PERPHENAZINE PERPHENAZINE 16MG TABLET;ORAL Prescription Yes AB 089686 SANDOZ
PERPHENAZINE PERPHENAZINE 16MG TABLET;ORAL Prescription No AB 040226 VINTAGE PHARMS
PERPHENAZINE PERPHENAZINE 16MG TABLET;ORAL Prescription No AB 207582 WATSON LABS INC
PERPHENAZINE PERPHENAZINE 16MG TABLET;ORAL Prescription No AB 205973 WILSHIRE PHARMS INC

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