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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217917
Company: BIONPHARMA

Products on ANDA 217917

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 217917

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217917

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

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