Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075898
Company: ANI PHARMS INC
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
03/12/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75898ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2008 SUPPL-20 Labeling

Label is not available on this site.

09/14/2007 SUPPL-19 Labeling

Label is not available on this site.

06/27/2007 SUPPL-18 Labeling

Label is not available on this site.

08/29/2006 SUPPL-17 Labeling

Label is not available on this site.

11/29/2005 SUPPL-16 Labeling

Label is not available on this site.

06/09/2005 SUPPL-14 Labeling

Label is not available on this site.

11/02/2004 SUPPL-8 Labeling

Label is not available on this site.

10/21/2002 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/20/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

10/30/2001 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

10/30/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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