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Last Updated: March 28, 2024

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 Pharma Ltd, Hikma, Hq Spclt Pharma, Mylan Labs Ltd, Pharmachemie Bv, and Teva Pharms Usa, and is included in nine NDAs. It is available from nine 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. Nine 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 206774
Medical Subject Heading (MeSH) Categories for 206774
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 16729-288 16729-288-11 50 mL in 1 VIAL (16729-288-11)
CISPLATIN cisplatin INJECTABLE;INJECTION 206774 ANDA Accord Healthcare 16729-288 16729-288-38 100 mL in 1 VIAL (16729-288-38)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Aug 18, 2015TE:APRLD:No

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