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Last Updated: December 27, 2024

Details for New Drug Application (NDA): 074656


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NDA 074656 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 074656
Tradename:CISPLATIN
Applicant:Pharmachemie Bv
Ingredient:cisplatin
Patents:0
Pharmacology for NDA: 074656
Medical Subject Heading (MeSH) Categories for 074656
Suppliers and Packaging for NDA: 074656
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CISPLATIN cisplatin INJECTABLE;INJECTION 074656 ANDA Teva Parenteral Medicines, Inc. 0703-5747 0703-5747-11 1 VIAL, MULTI-DOSE in 1 CARTON (0703-5747-11) / 50 mL in 1 VIAL, MULTI-DOSE
CISPLATIN cisplatin INJECTABLE;INJECTION 074656 ANDA Teva Parenteral Medicines, Inc. 0703-5748 0703-5748-11 1 VIAL, MULTI-DOSE in 1 CARTON (0703-5748-11) / 100 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:May 16, 2000TE:APRLD:No

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