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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 075036

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NDA 075036 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 075036

Tradename:	CISPLATIN
Applicant:	Hikma
Ingredient:	cisplatin
Patents:	0

Pharmacology for NDA: 075036

Medical Subject Heading (MeSH) Categories for 075036

Antineoplastic Agents
Cross-Linking Reagents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 075036

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISPLATIN	cisplatin	INJECTABLE;INJECTION	075036	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9504	0143-9504-01	1 VIAL, MULTI-DOSE in 1 CARTON (0143-9504-01) / 50 mL in 1 VIAL, MULTI-DOSE
CISPLATIN	cisplatin	INJECTABLE;INJECTION	075036	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9505	0143-9505-01	1 VIAL, MULTI-DOSE in 1 CARTON (0143-9505-01) / 100 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Nov 7, 2000	TE:	AP	RLD:	No

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