Details for New Drug Application (NDA): 216983
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NDA 216983 describes PYRIMETHAMINE, which is a drug marketed by Alvogen, Aurobindo Pharma Ltd, Sanaluz, and Teva Pharms, and is included in four NDAs. It is available from four suppliers. Additional details are available on the PYRIMETHAMINE profile page.
The generic ingredient in PYRIMETHAMINE is pyrimethamine. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pyrimethamine profile page.
The generic ingredient in PYRIMETHAMINE is pyrimethamine. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pyrimethamine profile page.
Summary for 216983
| Tradename: | PYRIMETHAMINE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | pyrimethamine |
| Patents: | 0 |
Pharmacology for NDA: 216983
| Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 216983
Suppliers and Packaging for NDA: 216983
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRIMETHAMINE | pyrimethamine | TABLET;ORAL | 216983 | ANDA | Aurobindo Pharma Limited | 59651-590 | 59651-590-01 | 100 TABLET in 1 BOTTLE (59651-590-01) |
| PYRIMETHAMINE | pyrimethamine | TABLET;ORAL | 216983 | ANDA | Aurobindo Pharma Limited | 59651-590 | 59651-590-30 | 30 TABLET in 1 BOTTLE (59651-590-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 25, 2022 | TE: | AB | RLD: | No | ||||
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