Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076125
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 25MG TABLET;ORAL Discontinued None No No
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 50MG TABLET;ORAL Discontinued None No No
FLUVOXAMINE MALEATE FLUVOXAMINE MALEATE 100MG 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
04/29/2002 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
06/27/2007 SUPPL-14 Labeling

Label is not available on this site.

05/12/2007 SUPPL-13 Labeling

Label is not available on this site.

02/21/2007 SUPPL-12 Labeling

Label is not available on this site.

07/24/2006 SUPPL-11 Labeling

Label is not available on this site.

10/20/2004 SUPPL-4 Labeling

Label is not available on this site.

02/13/2004 SUPPL-3 Labeling

Label is not available on this site.

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