Details for New Drug Application (NDA): 214809
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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 214809
Tradename: | NELARABINE |
Applicant: | Shorla |
Ingredient: | nelarabine |
Patents: | 0 |
Pharmacology for NDA: 214809
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 214809
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 214809 | ANDA | AqVida GmbH | 80978-111 | 80978-111-06 | 6 BOTTLE in 1 CARTON (80978-111-06) / 50 mL in 1 BOTTLE (80978-111-01) |
NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 214809 | ANDA | Shorla Oncology Inc. | 81927-111 | 81927-111-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-01) / 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: | Mar 3, 2023 | TE: | AP | RLD: | No |
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