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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208209
Company: ACCORD HLTHCARE

Products on ANDA 208209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	AB	No	No
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2021	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
01/03/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/11/2024	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/07/2023	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208209

VILAZODONE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VIIBRYD	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	022567	ABBVIE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208209	ACCORD HLTHCARE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208202	ALEMBIC
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208228	APOTEX
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208200	INVAGEN PHARMS
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208212	TEVA PHARMS USA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VIIBRYD	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	Yes	AB	022567	ABBVIE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208209	ACCORD HLTHCARE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208202	ALEMBIC
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208228	APOTEX
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208200	INVAGEN PHARMS
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208212	TEVA PHARMS USA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VIIBRYD	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	Yes	AB	022567	ABBVIE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208209	ACCORD HLTHCARE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208202	ALEMBIC
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208228	APOTEX
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208200	INVAGEN PHARMS
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208212	TEVA PHARMS USA

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