Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075716
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Discontinued None No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Discontinued None No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Discontinued None No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Discontinued None 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
03/08/2004 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
03/06/2009 SUPPL-11 Labeling

Label is not available on this site.

07/09/2007 SUPPL-10 Labeling

Label is not available on this site.

07/09/2007 SUPPL-9 Labeling

Label is not available on this site.

02/27/2007 SUPPL-6 Labeling

Label is not available on this site.

02/27/2007 SUPPL-5 Labeling

Label is not available on this site.

03/24/2006 SUPPL-4 Labeling

Label is not available on this site.

10/25/2005 SUPPL-3 Labeling

Label is not available on this site.

03/10/2005 SUPPL-2 Labeling

Label is not available on this site.

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