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Details for New Drug Application (NDA): 089515

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NDA 089515 describes VINBLASTINE SULFATE, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hospira, and West-ward Pharms Int, and is included in four NDAs. It is available from one supplier. Additional details are available on the VINBLASTINE SULFATE profile page.

The generic ingredient in VINBLASTINE SULFATE is vinblastine sulfate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the vinblastine sulfate profile page.

Summary for NDA: 089515

Formulation / Manufacturing:see details

Pharmacology for NDA: 089515

Ingredient-typeVinca Alkaloids

Suppliers and Packaging for NDA: 089515

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vinblastine sulfate
INJECTABLE;INJECTION 089515 ANDA Fresenius Kabi USA, LLC 63323-278 63323-278-10 1 VIAL, MULTI-DOSE in 1 BOX (63323-278-10) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Apr 29, 1987TE:RLD:No

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