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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216990
Company: TORRENT

Products on ANDA 216990

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VENXXIVA	TIOPRONIN	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
VENXXIVA	TIOPRONIN	300MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216990

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216990Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2024	SUPPL-1	Labeling-Proprietary Name Change, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216990

VENXXIVA

TABLET, DELAYED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIOLA EC	TIOPRONIN	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	211843	MISSION PHARMACAL
TIOPRONIN	TIOPRONIN	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217219	PH HEALTH
TIOPRONIN	TIOPRONIN	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216456	TEVA PHARMS INC
VENXXIVA	TIOPRONIN	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216990	TORRENT

TABLET, DELAYED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIOLA EC	TIOPRONIN	300MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	211843	MISSION PHARMACAL
TIOPRONIN	TIOPRONIN	300MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217219	PH HEALTH
TIOPRONIN	TIOPRONIN	300MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216456	TEVA PHARMS INC
VENXXIVA	TIOPRONIN	300MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216990	TORRENT

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