Details for New Drug Application (NDA): 207127
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NDA 207127 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 207127
| Tradename: | PYRIMETHAMINE |
| Applicant: | Sanaluz |
| Ingredient: | pyrimethamine |
| Patents: | 0 |
Pharmacology for NDA: 207127
| Mechanism of Action | Dihydrofolate Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 207127
Suppliers and Packaging for NDA: 207127
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRIMETHAMINE | pyrimethamine | TABLET;ORAL | 207127 | ANDA | DR.REDDYS LABORATORIES INC | 43598-672 | 43598-672-01 | 100 TABLET in 1 BOTTLE, PLASTIC (43598-672-01) |
| PYRIMETHAMINE | pyrimethamine | TABLET;ORAL | 207127 | ANDA | DR.REDDYS LABORATORIES INC | 43598-672 | 43598-672-30 | 30 TABLET in 1 BOTTLE, PLASTIC (43598-672-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 28, 2020 | TE: | AB | RLD: | No | ||||
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