Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071443
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 50MG;4MG TABLET;ORAL Prescription None No Yes
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10MG;2MG TABLET;ORAL Prescription None No No
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10MG;4MG TABLET;ORAL Prescription None No No
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25MG;2MG TABLET;ORAL Prescription None No Yes
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25MG;4MG TABLET;ORAL Prescription None 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
11/10/1988 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-32 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/25/2016 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

12/13/2014 SUPPL-29 Labeling-Medication Guide

Label is not available on this site.

07/17/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071443s028lbl.pdf
09/21/2010 SUPPL-25 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/21/2009 SUPPL-24 Labeling

Label is not available on this site.

10/30/2008 SUPPL-23 Labeling

Label is not available on this site.

11/07/2007 SUPPL-21 Labeling

Label is not available on this site.

07/11/2007 SUPPL-20 Labeling

Label is not available on this site.

07/26/2005 SUPPL-15 Labeling

Label is not available on this site.

05/07/2002 SUPPL-12 Labeling

Label is not available on this site.

02/25/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/04/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/28/1995 SUPPL-8 Labeling

Label is not available on this site.

10/05/1993 SUPPL-7 Labeling

Label is not available on this site.

09/01/1993 SUPPL-6 Labeling

Label is not available on this site.

10/22/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/05/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/01/1989 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
07/17/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071443s028lbl.pdf

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