Details for New Drug Application (NDA): 204029
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The generic ingredient in CLOFARABINE is clofarabine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
Summary for 204029
Tradename: | CLOFARABINE |
Applicant: | Abon Pharms Llc |
Ingredient: | clofarabine |
Patents: | 0 |
Pharmacology for NDA: 204029
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 204029
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 204029 | ANDA | Zydus Lifesciences Limited | 49315-003 | 49315-003-06 | 1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 20 mL in 1 VIAL, SINGLE-USE |
CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 204029 | ANDA | Fresenius Kabi USA, LLC | 63323-572 | 63323-572-70 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) / 20 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/20ML (1MG/ML) | ||||
Approval Date: | May 9, 2017 | TE: | AP | RLD: | No |
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