Details for New Drug Application (NDA): 205919
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NDA 205919 describes PURIXAN, which is a drug marketed by Nova Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the PURIXAN profile page.
The generic ingredient in PURIXAN is mercaptopurine. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
The generic ingredient in PURIXAN is mercaptopurine. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mercaptopurine profile page.
Summary for 205919
| Tradename: | PURIXAN |
| Applicant: | Nova Labs Ltd |
| Ingredient: | mercaptopurine |
| Patents: | 0 |
Pharmacology for NDA: 205919
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 205919
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PURIXAN | mercaptopurine | SUSPENSION;ORAL | 205919 | NDA | Nova Laboratories, Ltd | 62484-0020 | 62484-0020-2 | 1 BOTTLE in 1 CARTON (62484-0020-2) / 100 mL in 1 BOTTLE (62484-0020-1) |
| PURIXAN | mercaptopurine | SUSPENSION;ORAL | 205919 | NDA | Nova Laboratories, Ltd | 62484-1020 | 62484-1020-4 | 1 BOTTLE in 1 CARTON (62484-1020-4) / 100 mL in 1 BOTTLE (62484-1020-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 20MG/ML | ||||
| Approval Date: | Apr 28, 2014 | TE: | AB | RLD: | Yes | ||||
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