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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214326
Company: TEVA PHARMS USA INC

Products on ANDA 214326

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214326

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214326Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214326

TIOPRONIN

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THIOLA	TIOPRONIN	100MG	TABLET;ORAL	Prescription	Yes	AB	019569	MISSION PHARMA
TIOPRONIN	TIOPRONIN	100MG	TABLET;ORAL	Prescription	No	AB	216198	PAR PHARM INC
TIOPRONIN	TIOPRONIN	100MG	TABLET;ORAL	Prescription	No	AB	214326	TEVA PHARMS USA INC

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