Details for New Drug Application (NDA): 216038
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NDA 216038 describes NELARABINE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Gland Pharma Ltd, Meitheal, MSN, Nexus, Shorla, Xgen Pharms, and Zydus Pharms, and is included in ten NDAs. It is available from twelve suppliers. Additional details are available on the NELARABINE profile page.
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.
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 216038
| Tradename: | NELARABINE |
| Applicant: | Meitheal |
| Ingredient: | nelarabine |
| Patents: | 0 |
Pharmacology for NDA: 216038
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 216038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216038 | ANDA | Meitheal Pharmaceuticals Inc | 71288-165 | 71288-165-53 | 6 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-53) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52) |
| NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216038 | ANDA | Meitheal Pharmaceuticals Inc | 71288-165 | 71288-165-54 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/50ML (5MG/ML) | ||||
| Approval Date: | Jan 10, 2023 | TE: | AP | RLD: | No | ||||
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