Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075901
Company: ACTAVIS ELIZABETH

• Other Important Information from FDA

Products on ANDA 075901

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 075901

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75901_Fluvoxamine Maleate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75901ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075901_fluvoxamine-maleate_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2002	SUPPL-2	Labeling		Label is not available on this site.
11/02/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075901

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75901_Fluvoxamine Maleate_Prntlbl.pdf