Details for New Drug Application (NDA): 212605
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The generic ingredient in NELARABINE is nelarabine. There are two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the nelarabine profile page.
Summary for 212605
Tradename: | NELARABINE |
Applicant: | Gland Pharma Ltd |
Ingredient: | nelarabine |
Patents: | 0 |
Pharmacology for NDA: 212605
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 212605
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 212605 | ANDA | Gland Pharma Limited | 68083-233 | 68083-233-06 | 6 VIAL, SINGLE-DOSE in 1 CARTON (68083-233-06) / 50 mL in 1 VIAL, SINGLE-DOSE (68083-233-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/50ML (5MG/ML) | ||||
Approval Date: | Jan 3, 2024 | TE: | AP | RLD: | No |
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