Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075899
Company: SYNTHON PHARMS
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
01/17/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75899ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/16/2007 SUPPL-10 Labeling

Label is not available on this site.

06/29/2007 SUPPL-9 Labeling

Label is not available on this site.

10/18/2006 SUPPL-8 Labeling

Label is not available on this site.

07/08/2005 SUPPL-7 Labeling

Label is not available on this site.

04/14/2005 SUPPL-6 Labeling

Label is not available on this site.

04/14/2005 SUPPL-5 Labeling

Label is not available on this site.

11/20/2004 SUPPL-4 Labeling

Label is not available on this site.

09/25/2003 SUPPL-3 Labeling

Label is not available on this site.

07/24/2002 SUPPL-2 Labeling

Label is not available on this site.

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