Last Updated: November 8, 2026

Details for New Drug Application (NDA): 074735

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NDA 074735 describes CISPLATIN, which is a drug marketed by Accord Hlthcare, Bedford, Fresenius Kabi Usa, Gland, Hikma, Hq Spclt Pharma, Pharmachemie Bv, Pharmobedient, Qilu, and Teva Pharms Usa, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the CISPLATIN profile page.

The generic ingredient in CISPLATIN is cisplatin. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the cisplatin profile page.

Summary for 074735

Tradename:	CISPLATIN
Applicant:	Fresenius Kabi Usa
Ingredient:	cisplatin
Patents:	0

Pharmacology for NDA: 074735

Medical Subject Heading (MeSH) Categories for 074735

Antineoplastic Agents
Cross-Linking Reagents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 074735

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISPLATIN	cisplatin	INJECTABLE;INJECTION	074735	ANDA	Fresenius Kabi USA, LLC	63323-103	63323-103-51	1 VIAL in 1 CARTON (63323-103-51) / 50 mL in 1 VIAL
CISPLATIN	cisplatin	INJECTABLE;INJECTION	074735	ANDA	Fresenius Kabi USA, LLC	63323-103	63323-103-64	1 VIAL in 1 CARTON (63323-103-64) / 200 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Jul 16, 1999	TE:	AP	RLD:	No

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