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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076235

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NDA 076235 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 076235

Tradename:	CARBOPLATIN
Applicant:	Fresenius Kabi Usa
Ingredient:	carboplatin
Patents:	0

Medical Subject Heading (MeSH) Categories for 076235

Antineoplastic Agents
Cross-Linking Reagents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/VIAL
Approval Date:	Oct 14, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	150MG/VIAL
Approval Date:	Oct 14, 2004	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	450MG/VIAL
Approval Date:	Oct 14, 2004	TE:		RLD:	No

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