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US Department of Justice
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077269

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NDA 077269 describes CARBOPLATIN, which is a drug marketed by Cipla Ltd, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Pliva, Sandoz, Watson Labs Teva, West-ward Pharms Int, Accord Hlthcare, Actavis Totowa, Akorn, Eugia Pharma, Fresenius Kabi Oncol, Gland Pharma Ltd, Ingenus Pharms Llc, Mylan Institutional, Nanjing King-friend, Pharmachemie Bv, Pliva Lachema, Sandoz Inc, Sun Pharma Global, Teva Parenteral, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from twelve suppliers. Additional details are available on the CARBOPLATIN profile page.

The generic ingredient in CARBOPLATIN is carboplatin. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 077269
Tradename:CARBOPLATIN
Applicant:Pharmachemie Bv
Ingredient:carboplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077269
Medical Subject Heading (MeSH) Categories for 077269
Suppliers and Packaging for NDA: 077269
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPLATIN carboplatin INJECTABLE;IV (INFUSION) 077269 ANDA Teva Parenteral Medicines, Inc. 0703-4239 N 0703-4239-01
CARBOPLATIN carboplatin INJECTABLE;IV (INFUSION) 077269 ANDA Teva Parenteral Medicines, Inc. 0703-4239 N 0703-4239-81

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/5ML (10MG/ML)
Approval Date:Oct 14, 2004TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength150MG/15ML (10MG/ML)
Approval Date:Oct 14, 2004TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength450MG/45ML (10MG/ML)
Approval Date:Oct 14, 2004TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
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