Drugs@FDA: FDA Approved Drug Products

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

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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