Details for New Drug Application (NDA): 207831
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NDA 207831 describes CLOFARABINE, which is a drug marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hospira, Meitheal, MSN, Mylan Labs Ltd, and Novast Labs, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the CLOFARABINE profile page.
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.
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 207831
| Tradename: | CLOFARABINE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | clofarabine |
| Patents: | 0 |
Pharmacology for NDA: 207831
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 207831
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 207831 | ANDA | Gland Pharma Limited | 68083-386 | 68083-386-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
| CLOFARABINE | clofarabine | SOLUTION;INTRAVENOUS | 207831 | ANDA | Fosun Pharma USA Inc. | 72266-108 | 72266-108-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72266-108-01) / 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 31, 2018 | TE: | AP | RLD: | No | ||||
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