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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 077059

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NDA 077059 describes CARBOPLATIN, which is a drug marketed by Cipla Ltd, Fresenius Kabi Usa, Hikma, Hospira, Natco Pharma Usa, Pliva, Sandoz, Watson Labs Teva, Accord Hlthcare, Actavis Totowa, Epic Pharma Llc, Eugia Pharma, Gland, Meitheal, Novast Labs, Pharmachemie Bv, Pharmobedient, Pliva Lachema, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Teyro Labs, and is included in thirty-three NDAs. It is available from ten suppliers. Additional details are available on the CARBOPLATIN profile page.

The generic ingredient in CARBOPLATIN is carboplatin. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.

Summary for 077059

Tradename:	CARBOPLATIN
Applicant:	Hospira
Ingredient:	carboplatin
Patents:	0

Pharmacology for NDA: 077059

Medical Subject Heading (MeSH) Categories for 077059

Antineoplastic Agents
Cross-Linking Reagents

Suppliers and Packaging for NDA: 077059

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077059	ANDA	Hospira, Inc.	61703-600	61703-600-05	1 VIAL, MULTI-DOSE in 1 CARTON (61703-600-05) / 60 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	600MG/60ML (10MG/ML)
Approval Date:	Nov 23, 2004	TE:	AP	RLD:	No

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