Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040226
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERPHENAZINE PERPHENAZINE 2MG TABLET;ORAL Prescription AB No No
PERPHENAZINE PERPHENAZINE 4MG TABLET;ORAL Prescription AB No No
PERPHENAZINE PERPHENAZINE 8MG TABLET;ORAL Prescription AB No No
PERPHENAZINE PERPHENAZINE 16MG 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
12/31/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40226_Perphenazaine_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40226_Perphenazaine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040226_perphenazine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

12/06/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/18/2009 SUPPL-6 Labeling

Label is not available on this site.

04/30/2009 SUPPL-5 Labeling

Label is not available on this site.

11/28/2006 SUPPL-4 Labeling

Label is not available on this site.

06/22/2006 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
12/31/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40226_Perphenazaine_Prntlbl.pdf

PERPHENAZINE

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; 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; 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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