Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091476
Company: ENDO OPERATIONS

Products on ANDA 091476

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091476

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/2013	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091476Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2023	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
08/18/2023	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
08/10/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/16/2015	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 091476

FLUVOXAMINE MALEATE

CAPSULE, EXTENDED RELEASE;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	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	091482	ACTAVIS ELIZABETH
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	212182	BIONPHARMA
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	091476	ENDO OPERATIONS

CAPSULE, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	091482	ACTAVIS ELIZABETH
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	212182	BIONPHARMA
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	091476	ENDO OPERATIONS