Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077395
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML SUSPENSION;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
12/04/2006 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077395.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/19/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/31/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/05/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/07/2009 SUPPL-7 Labeling

Label is not available on this site.

05/07/2009 SUPPL-6 Labeling

Label is not available on this site.

12/15/2008 SUPPL-5 Labeling

Label is not available on this site.

07/09/2007 SUPPL-2 Labeling

Label is not available on this site.

07/09/2007 SUPPL-1 Labeling

Label is not available on this site.

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