Details for New Drug Application (NDA): 008578
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NDA 008578 describes DARAPRIM, which is a drug marketed by Tilde Sciences and is included in one NDA. It is available from three suppliers. Additional details are available on the DARAPRIM profile page.
The generic ingredient in DARAPRIM is pyrimethamine. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the pyrimethamine profile page.
The generic ingredient in DARAPRIM is pyrimethamine. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the pyrimethamine profile page.
Summary for 008578
| Tradename: | DARAPRIM |
| Applicant: | Tilde Sciences |
| Ingredient: | pyrimethamine |
| Patents: | 0 |
Pharmacology for NDA: 008578
| Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 008578
Suppliers and Packaging for NDA: 008578
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARAPRIM | pyrimethamine | TABLET;ORAL | 008578 | NDA | Vyera Pharmaceuticals LLC | 69413-330 | 69413-330-10 | 100 TABLET in 1 BOTTLE, PLASTIC (69413-330-10) |
| DARAPRIM | pyrimethamine | TABLET;ORAL | 008578 | NDA | Vyera Pharmaceuticals LLC | 69413-330 | 69413-330-30 | 30 TABLET in 1 BOTTLE, PLASTIC (69413-330-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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