Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091482
Company: ACTAVIS ELIZABETH

Products on ANDA 091482

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091482

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2013	ORIG-2	Approval				Label is not available on this site.
04/23/2013	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
02/12/2024	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/18/2023	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/10/2023	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
11/13/2020	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/13/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091482

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