Details for New Drug Application (NDA): 208867
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NDA 208867 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 208867
| Tradename: | PROPYLTHIOURACIL |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | propylthiouracil |
| Patents: | 0 |
Pharmacology for NDA: 208867
| Mechanism of Action | Thyroid Hormone Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 208867
Suppliers and Packaging for NDA: 208867
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPYLTHIOURACIL | propylthiouracil | TABLET;ORAL | 208867 | ANDA | Macleods Pharmaceuticals Limited | 33342-314 | 33342-314-11 | 100 TABLET in 1 BOTTLE (33342-314-11) |
| PROPYLTHIOURACIL | propylthiouracil | TABLET;ORAL | 208867 | ANDA | Macleods Pharmaceuticals Limited | 33342-314 | 33342-314-12 | 10 BLISTER PACK in 1 CARTON (33342-314-12) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | May 10, 2023 | TE: | AB | RLD: | No | ||||
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