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Serving 500+ biopharmaceutical companies globally:

Cipla
Fuji
UBS
Harvard Business School
Healthtrust
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McKinsey
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US Department of Justice

Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077926

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NDA 077926 describes CARBOPLATIN, which is a drug marketed by Pliva, Mylan Labs Ltd, Hospira, Gland Pharma Ltd, Sun Pharma Global, Pliva Lachema, Actavis Totowa, Fresenius Kabi Oncol, Fresenius Kabi Usa, Teva Pharms Usa, West-ward Pharms Int, Sandoz, Cipla Ltd, Watson Labs Teva, Akorn, Pharmachemie Bv, Accord Hlthcare, Sandoz Inc, Ingenus Pharms Llc, Sanja Pharms Co, Teva Parenteral, Nanjing King-friend, and Mylan Institutional, and is included in thirty-three NDAs. It is available from eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.

Summary for NDA: 077926

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 077926

Suppliers and Packaging for NDA: 077926

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPLATIN
carboplatin
INJECTABLE;IV (INFUSION) 077926 ANDA Sun Pharma Global FZE 47335-284 47335-284-40 1 VIAL, MULTI-DOSE in 1 CARTON (47335-284-40) > 60 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/5ML (10MG/ML)
Approval Date:Sep 19, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength150MG/15ML (10MG/ML)
Approval Date:Sep 19, 2008TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength450MG/45ML (10MG/ML)
Approval Date:Sep 19, 2008TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cipla
Teva
QuintilesIMS
AstraZeneca
Queensland Health
Merck
Moodys
Deloitte
Mallinckrodt
Citi

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