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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 218868

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NDA 218868 describes CISPLATIN, which is a drug marketed by Accord Hlthcare, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Norvium Bioscience, Pharmachemie Bv, 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 218868

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

Pharmacology for NDA: 218868

Medical Subject Heading (MeSH) Categories for 218868

Antineoplastic Agents
Cross-Linking Reagents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 218868

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISPLATIN	cisplatin	INJECTABLE;INJECTION	218868	ANDA	Apotex Corp.	60505-6279	60505-6279-0	1 VIAL, MULTI-DOSE in 1 CARTON (60505-6279-0) / 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	May 10, 2024	TE:	AP	RLD:	No

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