Details for New Drug Application (NDA): 215506
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NDA 215506 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 five 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the pyrimethamine profile page.
Summary for 215506
| Tradename: | PYRIMETHAMINE |
| Applicant: | Teva Pharms |
| Ingredient: | pyrimethamine |
| Patents: | 0 |
Pharmacology for NDA: 215506
| Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215506
Suppliers and Packaging for NDA: 215506
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRIMETHAMINE | pyrimethamine | TABLET;ORAL | 215506 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3720 | 0480-3720-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0480-3720-01) |
| PYRIMETHAMINE | pyrimethamine | TABLET;ORAL | 215506 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3720 | 0480-3720-56 | 30 TABLET in 1 BOTTLE, PLASTIC (0480-3720-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 13, 2021 | TE: | AB | RLD: | No | ||||
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