Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Chinese Patent Office
Harvard Business School
UBS
Johnson and Johnson

Generated: July 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207831

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NDA 207831 describes CLOFARABINE, which is a drug marketed by Abon Pharms Llc, Accord Hlthcare, Amneal Pharms Co, Dr Reddys Labs Ltd, Gland Pharma Ltd, Hospira Inc, Ingenus Pharms Llc, Msn Labs Pvt Ltd, and Mylan Labs Ltd, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the CLOFARABINE profile page.

The generic ingredient in CLOFARABINE is clofarabine. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
Summary for 207831
Tradename:CLOFARABINE
Applicant:Gland Pharma Ltd
Ingredient:clofarabine
Patents:0
Pharmacology for NDA: 207831
Suppliers and Packaging for NDA: 207831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 207831 ANDA Gland Pharma Limited 68083-386 68083-386-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) > 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/20ML (1MG/ML)
Approval Date:Oct 31, 2018TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Merck
Cantor Fitzgerald
US Department of Justice
Fuji
Argus Health

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