Details for New Drug Application (NDA): 080016
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NDA 080016 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.
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 080016
| Tradename: | PROPYLTHIOURACIL |
| Applicant: | Chartwell Molecular |
| Ingredient: | propylthiouracil |
| Patents: | 0 |
Pharmacology for NDA: 080016
| Mechanism of Action | Thyroid Hormone Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 080016
Suppliers and Packaging for NDA: 080016
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPYLTHIOURACIL | propylthiouracil | TABLET;ORAL | 080016 | ANDA | Chartwell RX, LLC | 62135-606 | 62135-606-90 | 90 TABLET in 1 BOTTLE (62135-606-90) |
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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