Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020243
Company: SOLVAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUVOX FLUVOXAMINE MALEATE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
LUVOX FLUVOXAMINE MALEATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
LUVOX FLUVOXAMINE MALEATE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
LUVOX FLUVOXAMINE MALEATE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/05/1994 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2001 SUPPL-23 Labeling

Label is not available on this site.

08/09/2000 SUPPL-22 Labeling

Label is not available on this site.

09/28/2000 SUPPL-21 Efficacy-New Dosing Regimen Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20243S21ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-243S021.pdf
06/01/2000 SUPPL-20 Labeling

Label is not available on this site.

06/01/2000 SUPPL-19 Labeling

Label is not available on this site.

10/21/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/08/1998 SUPPL-15 Labeling

Label is not available on this site.

06/01/2000 SUPPL-14 Labeling

Label is not available on this site.

06/01/2000 SUPPL-13 Labeling

Label is not available on this site.

11/13/1996 SUPPL-9 Labeling

Label is not available on this site.

12/02/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/25/1997 SUPPL-6 Efficacy-New Patient Population

Label is not available on this site.

03/19/1996 SUPPL-5 Labeling

Label is not available on this site.

01/18/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/12/1995 SUPPL-2 Labeling

Label is not available on this site.

02/21/1995 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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