Details for New Drug Application (NDA): 215037
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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 215037
Tradename: | NELARABINE |
Applicant: | Zydus Pharms |
Ingredient: | nelarabine |
Patents: | 0 |
Pharmacology for NDA: 215037
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 215037
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 215037 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1726 | 70710-1726-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1726-1) / 50 mL in 1 VIAL, SINGLE-DOSE |
NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 215037 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1726 | 70710-1726-8 | 6 VIAL, SINGLE-DOSE in 1 CARTON (70710-1726-8) / 50 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/50ML (5MG/ML) | ||||
Approval Date: | Nov 17, 2021 | TE: | AP | RLD: | No |
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