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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040226
Company: VINTAGE PHARMS

Products on ANDA 040226

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040226

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.

Labels for ANDA 040226

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

Therapeutic Equivalents for ANDA 040226

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	210163	APPCO
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
PERPHENAZINE	PERPHENAZINE	2MG	TABLET;ORAL	Prescription	No	AB	205232	ZYDUS PHARMS

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	210163	APPCO
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
PERPHENAZINE	PERPHENAZINE	4MG	TABLET;ORAL	Prescription	No	AB	205232	ZYDUS PHARMS

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	210163	APPCO
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
PERPHENAZINE	PERPHENAZINE	8MG	TABLET;ORAL	Prescription	No	AB	205232	ZYDUS PHARMS

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	210163	APPCO
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
PERPHENAZINE	PERPHENAZINE	16MG	TABLET;ORAL	Prescription	No	AB	205232	ZYDUS PHARMS

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