Last Updated: November 8, 2026

Details for New Drug Application (NDA): 216198

NDA 216198 describes TIOPRONIN, which is a drug marketed by Amneal, Ph Health, Teva Pharms Inc, and Teva Pharms Usa Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the TIOPRONIN profile page.

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

Summary for 216198

Tradename:	TIOPRONIN
Applicant:	Ph Health
Ingredient:	tiopronin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jun 2, 2022	TE:		RLD:	No

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