Last Updated: September 24, 2026

Details for New Drug Application (NDA): 080215

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NDA 080215 describes PROPYLTHIOURACIL, which is a drug marketed by Abbott, Actavis Elizabeth, Anabolic, Ani Pharms, Chartwell Molecular, Chartwell Rx, Halsey, Impax Labs, Lilly, Macleods Pharms, Ph Health, Quagen, Sun Pharm Industries, Tablicaps, and Watson Labs, and is included in sixteen NDAs. It is available from seven suppliers. Additional details are available on the PROPYLTHIOURACIL profile page.

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

Summary for 080215

Tradename:	PROPYLTHIOURACIL
Applicant:	Ani Pharms
Ingredient:	propylthiouracil
Patents:	0

Medical Subject Heading (MeSH) Categories for 080215

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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