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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216278

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NDA 216278 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. Six suppliers are listed for this compound. Additional details are available on the tiopronin profile page.

Summary for 216278

Tradename:	TIOPRONIN
Applicant:	Amneal
Ingredient:	tiopronin
Patents:	0

Pharmacology for NDA: 216278

Mechanism of Action	Cystine Disulfide Reduction

Suppliers and Packaging for NDA: 216278

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIOPRONIN	tiopronin	TABLET, DELAYED RELEASE;ORAL	216278	ANDA	Amneal Pharmaceuticals NY LLC	60219-2009	60219-2009-9	90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	300MG
Approval Date:	Aug 15, 2023	TE:	AB	RLD:	No

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