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Details for New Drug Application (NDA): 074656

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NDA 074656 describes CISPLATIN, which is a drug marketed by Bedford, Teva Pharms Usa, Fresenius Kabi Usa, Eurohlth Intl Sarl, Pharmachemie Bv, Hq Spclt Pharma, Mylan Labs Ltd, and Accord Hlthcare, and is included in eight NDAs. It is available from eight 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. Eight suppliers are listed for this compound. Additional details are available on the cisplatin profile page.

Summary for NDA: 074656

Pharmachemie Bv

Pharmacology for NDA: 074656

Suppliers and Packaging for NDA: 074656

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

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

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