Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075893
Company: TEVA

• Other Important Information from FDA

Products on ANDA 075893

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075893

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2002	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
08/18/2023	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/10/2023	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/15/2009	SUPPL-11	Labeling		Label is not available on this site.
09/10/2009	SUPPL-10	Labeling		Label is not available on this site.
09/18/2008	SUPPL-9	Labeling		Label is not available on this site.
11/28/2007	SUPPL-7	Labeling		Label is not available on this site.
06/27/2007	SUPPL-6	Labeling		Label is not available on this site.
07/24/2006	SUPPL-5	Labeling		Label is not available on this site.
05/03/2005	SUPPL-4	Labeling		Label is not available on this site.
10/20/2004	SUPPL-3	Labeling		Label is not available on this site.
05/18/2004	SUPPL-2	Labeling		Label is not available on this site.
11/20/2003	SUPPL-1	Labeling		Label is not available on this site.