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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 091478

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NDA 091478 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 Pharma Ltd, Meitheal, Norvium Bioscience, Novast Labs, Pharmachemie Bv, Pliva Lachema, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Teyro Labs, and is included in thirty-three NDAs. It is available from eleven 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 091478

Tradename:	CARBOPLATIN
Applicant:	Norvium Bioscience
Ingredient:	carboplatin
Patents:	0

Medical Subject Heading (MeSH) Categories for 091478

Antineoplastic Agents
Cross-Linking Reagents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	1GM/100ML (10MG/ML)
Approval Date:	Nov 23, 2011	TE:		RLD:	No

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