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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 091063

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NDA 091063 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, Qilu Pharm Hainan, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Teyro Labs, and is included in thirty-four NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the carboplatin profile page.

Summary for 091063

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

Medical Subject Heading (MeSH) Categories for 091063

Antineoplastic Agents
Cross-Linking Reagents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Nov 9, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	150MG/15ML (10MG/ML)
Approval Date:	Nov 9, 2011	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	450MG/45ML (10MG/ML)
Approval Date:	Nov 9, 2011	TE:		RLD:	No

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