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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 206774

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NDA 206774 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 are fourteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cisplatin profile page.

Summary for 206774

Tradename:	CISPLATIN
Applicant:	Accord Hlthcare
Ingredient:	cisplatin
Patents:	0

Pharmacology for NDA: 206774

Medical Subject Heading (MeSH) Categories for 206774

Antineoplastic Agents
Cross-Linking Reagents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 206774

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISPLATIN	cisplatin	INJECTABLE;INJECTION	206774	ANDA	Accord Healthcare Inc.	16729-288	16729-288-11	50 mL in 1 VIAL (16729-288-11)
CISPLATIN	cisplatin	INJECTABLE;INJECTION	206774	ANDA	Accord Healthcare Inc.	16729-288	16729-288-38	100 mL in 1 VIAL (16729-288-38)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Aug 18, 2015	TE:	AP	RLD:	No

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