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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212182
Company: BIONPHARMA

Products on ANDA 212182

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212182

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/18/2023	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212182

FLUVOXAMINE MALEATE

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	219055	AJANTA PHARMA LTD
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	217024	ANNORA PHARMA
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	PH HEALTH

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	219055	AJANTA PHARMA LTD
FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	217024	ANNORA PHARMA
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	PH HEALTH

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