Suppliers and packages for generic ingredient: NELARABINE
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NELARABINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
---|---|---|---|---|---|---|---|---|---|
Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877 | NDA | Novartis Pharmaceuticals Corporation | 0078-0683-61 | 50 mL in 1 VIAL (0078-0683-61) | 2016-10-05 |
Amneal | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216346 | ANDA | Amneal Pharmaceuticals LLC | 70121-1743-4 | 6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE (70121-1743-1) | 2023-04-10 |
Dr Reddys | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216934 | ANDA | Dr. Reddy's Laboratories, Inc. | 43598-142-06 | 6 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-06) / 50 mL in 1 VIAL, SINGLE-DOSE | 2023-01-09 |
Dr Reddys | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216934 | ANDA | Dr. Reddy's Laboratories, Inc. | 43598-142-11 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-11) / 50 mL in 1 VIAL, SINGLE-DOSE | 2023-01-09 |
Gland Pharma Ltd | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 212605 | ANDA | Gland Pharma Limited | 68083-233-06 | 6 VIAL, SINGLE-DOSE in 1 CARTON (68083-233-06) / 50 mL in 1 VIAL, SINGLE-DOSE (68083-233-01) | 2024-01-03 |
Kindos | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216038 | ANDA | Meitheal Pharmaceuticals Inc | 71288-165-53 | 6 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-53) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52) | 2023-01-10 |
Kindos | NELARABINE | nelarabine | INJECTABLE;INTRAVENOUS | 216038 | ANDA | Meitheal Pharmaceuticals Inc | 71288-165-54 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52) | 2023-01-10 |
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