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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040209
Company: MYLAN

Products on ANDA 040209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	No	No
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	AB	No	No
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/1997	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
01/22/2025	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/14/2025	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-11	Labeling		Label is not available on this site.
05/22/2009	SUPPL-9	Labeling		Label is not available on this site.
09/08/2008	SUPPL-8	Labeling		Label is not available on this site.
08/19/2008	SUPPL-5	Labeling		Label is not available on this site.
06/13/2003	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040209

TRIFLUOPERAZINE HYDROCHLORIDE

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	040209	MYLAN
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	085785	SANDOZ

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	040209	MYLAN
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	085786	SANDOZ

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	040209	MYLAN
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	085789	SANDOZ

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	040209	MYLAN
TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	085788	SANDOZ

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