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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080172

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NDA 080172 describes PROPYLTHIOURACIL, which is a drug marketed by Abbott, Actavis Elizabeth, Anabolic, Ani Pharms Inc, Chartwell Rx, Dava Pharms Inc, Halsey, Hikma Intl Pharms, Impax Labs, Lannett, Lilly, Sun Pharm Industries, Tablicaps, and Watson Labs, and is included in fifteen NDAs. It is available from seven 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. Seven suppliers are listed for this compound. Additional details are available on the propylthiouracil profile page.
Summary for 080172
Applicant:Actavis Elizabeth
Therapeutic Class:Hormonal Agents, Suppressant (Thyroid)
Formulation / Manufacturing:see details
Pharmacology for NDA: 080172
Medical Subject Heading (MeSH) Categories for 080172
Suppliers and Packaging for NDA: 080172
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPYLTHIOURACIL propylthiouracil TABLET;ORAL 080172 ANDA Actavis Pharma, Inc. 0228-2348 N 0228-2348-10
PROPYLTHIOURACIL propylthiouracil TABLET;ORAL 080172 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7583 N 0615-7583-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:BDRLD:No

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