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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 084543

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NDA 084543 describes PROPYLTHIOURACIL, which is a drug marketed by Abbott, Actavis Elizabeth, Anabolic, Ani Pharms, Chartwell Molecular, Chartwell Rx, Endo Operations, Halsey, Impax Labs, Lilly, Macleods Pharms Ltd, Quagen, Sun Pharm Industries, Tablicaps, and Watson Labs, and is included in sixteen NDAs. It is available from eight suppliers. Additional details are available on the PROPYLTHIOURACIL profile page.

The generic ingredient in PROPYLTHIOURACIL is propylthiouracil. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the propylthiouracil profile page.

Summary for 084543

Tradename:	PROPYLTHIOURACIL
Applicant:	Chartwell Rx
Ingredient:	propylthiouracil
Patents:	0

Medical Subject Heading (MeSH) Categories for 084543

Antimetabolites
Antithyroid Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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