Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075887
Company: UPSHER SMITH LABS

• Other Important Information from FDA

Products on ANDA 075887

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 075887

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75887ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2003	SUPPL-7	Labeling		Label is not available on this site.
11/26/2001	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/26/2001	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.