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Details for New Drug Application (NDA): 075493

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NDA 075493 describes VINCRISTINE SULFATE PFS, which is a drug marketed by Hospira and Teva Pharms Usa and is included in two NDAs. It is available from two suppliers. Additional details are available on the VINCRISTINE SULFATE PFS profile page.

The generic ingredient in VINCRISTINE SULFATE PFS is vincristine sulfate. There are thirteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vincristine sulfate profile page.

Summary for NDA: 075493

Teva Pharms Usa
vincristine sulfate

Pharmacology for NDA: 075493

Ingredient-typeVinca Alkaloids

Suppliers and Packaging for NDA: 075493

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vincristine sulfate
INJECTABLE;INJECTION 075493 ANDA Teva Parenteral Medicines, Inc. 0703-4402 0703-4402-11 1 VIAL, SINGLE-USE in 1 CARTON (0703-4402-11) > 1 mL in 1 VIAL, SINGLE-USE
vincristine sulfate
INJECTABLE;INJECTION 075493 ANDA Teva Parenteral Medicines, Inc. 0703-4412 0703-4412-11 1 VIAL, SINGLE-USE in 1 CARTON (0703-4412-11) > 2 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Sep 1, 1999TE:APRLD:No

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