Details for New Drug Application (NDA): 021877
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The generic ingredient in ARRANON 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 021877
Tradename: | ARRANON |
Applicant: | Sandoz |
Ingredient: | nelarabine |
Patents: | 0 |
Pharmacology for NDA: 021877
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 021877
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877 | NDA | Novartis Pharmaceuticals Corporation | 0078-0683 | 0078-0683-61 | 50 mL in 1 VIAL (0078-0683-61) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/50ML (5MG/ML) | ||||
Approval Date: | Oct 28, 2005 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 021877
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | ARRANON | nelarabine | INJECTABLE;INTRAVENOUS | 021877-001 | Oct 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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