Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075902
Company: APOTEX

• Other Important Information from FDA

Products on ANDA 075902

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET;ORAL	Prescription	AB	No	No
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET;ORAL	Prescription	AB	No	No
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075902

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/07/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75902ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/27/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
12/19/2022	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
12/19/2022	SUPPL-26	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
12/17/2020	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/17/2020	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/28/2015	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/28/2015	SUPPL-18	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/19/2010	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
06/03/2009	SUPPL-16	Labeling		Label is not available on this site.
06/27/2007	SUPPL-13	Labeling		Label is not available on this site.
07/24/2006	SUPPL-12	Labeling		Label is not available on this site.
07/24/2006	SUPPL-11	Labeling		Label is not available on this site.
07/08/2005	SUPPL-10	Labeling		Label is not available on this site.
10/20/2004	SUPPL-6	Labeling		Label is not available on this site.
05/14/2004	SUPPL-5	Labeling		Label is not available on this site.
02/20/2004	SUPPL-4	Labeling		Label is not available on this site.
01/14/2003	SUPPL-2	Labeling		Label is not available on this site.
11/27/2002	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Therapeutic Equivalents for ANDA 075902

FLUVOXAMINE MALEATE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET;ORAL	Prescription	No	AB	075902	APOTEX
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET;ORAL	Prescription	No	AB	217917	BIONPHARMA
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET;ORAL	Prescription	No	AB	075888	UPSHER SMITH LABS
LUVOX	FLUVOXAMINE MALEATE	25MG	TABLET;ORAL	Prescription	Yes	AB	021519	ANI PHARMS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET;ORAL	Prescription	No	AB	075902	APOTEX
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET;ORAL	Prescription	No	AB	217917	BIONPHARMA
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET;ORAL	Prescription	No	AB	075888	UPSHER SMITH LABS
LUVOX	FLUVOXAMINE MALEATE	50MG	TABLET;ORAL	Prescription	Yes	AB	021519	ANI PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET;ORAL	Prescription	No	AB	075902	APOTEX
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET;ORAL	Prescription	No	AB	217917	BIONPHARMA
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET;ORAL	Prescription	No	AB	075888	UPSHER SMITH LABS
LUVOX	FLUVOXAMINE MALEATE	100MG	TABLET;ORAL	Prescription	Yes	AB	021519	ANI PHARMS