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Last Updated: September 27, 2020

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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 Pharma Ltd, Hq Spclt Pharma, Mylan Labs Ltd, Pharmachemie Bv, Teva Pharms Usa, and West-ward Pharms Int, and is included in nine 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 075036
Tradename:CISPLATIN
Applicant:West-ward Pharms Int
Ingredient:cisplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075036
Medical Subject Heading (MeSH) Categories for 075036
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 West-Ward Pharmaceuticals Corp 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 West-Ward Pharmaceuticals Corp 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:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Nov 7, 2000TE:APRLD:No

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