Details for New Drug Application (NDA): 008578
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The generic ingredient in DARAPRIM is pyrimethamine. There are three drug master file entries for this compound. Eight 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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