Details for New Drug Application (NDA): 090724
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NDA 090724 describes FLUDARABINE PHOSPHATE, which is a drug marketed by Actavis Llc, Actavis Totowa, Areva Pharms, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Rising, Sagent Pharms Inc, and Sandoz, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the FLUDARABINE PHOSPHATE profile page.
The generic ingredient in FLUDARABINE PHOSPHATE is fludarabine phosphate. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.
The generic ingredient in FLUDARABINE PHOSPHATE is fludarabine phosphate. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.
Summary for 090724
| Tradename: | FLUDARABINE PHOSPHATE |
| Applicant: | Areva Pharms |
| Ingredient: | fludarabine phosphate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090724
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 090724
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 090724 | ANDA | Lannett Company, Inc. | 0527-1242 | 0527-1242-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0527-1242-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
| FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 090724 | ANDA | Areva Pharmaceuticals | 59923-604 | 59923-604-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (59923-604-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/2ML (25MG/ML) | ||||
| Approval Date: | Sep 27, 2010 | TE: | AP1 | RLD: | No | ||||
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