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Generated: April 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076349

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NDA 076349 describes FLUDARABINE PHOSPHATE, which is a drug marketed by Actavis Totowa, Mustafa Nevzat Ilac, Sandoz, Actavis Llc, Fresenius Kabi Usa, Mylan Labs Ltd, Sagent Pharms, and Hospira, and is included in eleven NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.

Summary for NDA: 076349

Formulation / Manufacturing:see details

Pharmacology for NDA: 076349

Suppliers and Packaging for NDA: 076349

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fludarabine phosphate
INJECTABLE;INJECTION 076349 ANDA Teva Parenteral Medicines, Inc. 0703-5854 0703-5854-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-5854-01) > 2 mL in 1 VIAL, SINGLE-DOSE
fludarabine phosphate
INJECTABLE;INJECTION 076349 ANDA Sagent Pharmaceuticals 25021-237 25021-237-06 1 VIAL in 1 CARTON (25021-237-06) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Aug 28, 2003TE:APRLD:No

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