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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 214326

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NDA 214326 describes TIOPRONIN, which is a drug marketed by Amneal, Endo Operations, Teva Pharms Inc, Torrent, and Teva Pharms Usa Inc, and is included in six NDAs. It is available from five suppliers. Additional details are available on the TIOPRONIN profile page.

The generic ingredient in TIOPRONIN is tiopronin. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tiopronin profile page.

Summary for 214326

Tradename:	TIOPRONIN
Applicant:	Teva Pharms Usa Inc
Ingredient:	tiopronin
Patents:	0

Pharmacology for NDA: 214326

Mechanism of Action	Cystine Disulfide Reduction

Suppliers and Packaging for NDA: 214326

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIOPRONIN	tiopronin	TABLET;ORAL	214326	ANDA	Teva Pharmaceuticals USA, Inc.	0093-7909	0093-7909-01	100 TABLET, SUGAR COATED in 1 BOTTLE (0093-7909-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 26, 2021	TE:	AB	RLD:	No

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