Details for New Drug Application (NDA): 216346
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The generic ingredient in NELARABINE is nelarabine. There are two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.
Summary for 216346
Tradename: | NELARABINE |
Applicant: | Amneal |
Ingredient: | nelarabine |
Patents: | 0 |
Pharmacology for NDA: 216346
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 216346
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216346 | ANDA | Amneal Pharmaceuticals LLC | 70121-1743 | 70121-1743-4 | 6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE (70121-1743-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/50ML (5MG/ML) | ||||
Approval Date: | Apr 4, 2023 | TE: | AP | RLD: | No |
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