Details for New Drug Application (NDA): 213461
NDA 213461 describes CLOFARABINE, which is a drug marketed by Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland, Hospira, Ingenus Pharms Llc, Meitheal, MLV, MSN, Pharmobedient, and Scinopharm Taiwan, and is included in twelve NDAs. It is available from nine suppliers. Additional details are available on the CLOFARABINE profile page.
The generic ingredient in CLOFARABINE is clofarabine. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
The generic ingredient in CLOFARABINE is clofarabine. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
Summary for 213461
| Tradename: | CLOFARABINE |
| Applicant: | Meitheal |
| Ingredient: | clofarabine |
| Patents: | 0 |
Pharmacology for NDA: 213461
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 213461
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 213461 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-128 | 71288-128-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-128-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/20ML (1MG/ML) | ||||
| Approval Date: | Oct 23, 2020 | TE: | AP | RLD: | No | ||||
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