Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020243
Company: SOLVAY

Products on NDA 020243

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LUVOX	FLUVOXAMINE MALEATE	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
LUVOX	FLUVOXAMINE MALEATE	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
LUVOX	FLUVOXAMINE MALEATE	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
LUVOX	FLUVOXAMINE MALEATE	150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020243

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.