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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Generated: July 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208857

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NDA 208857 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 208857
Applicant:Amneal Pharms Co
Pharmacology for NDA: 208857
Suppliers and Packaging for NDA: 208857
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 208857 ANDA Amneal Biosciences LLC 70121-1236 70121-1236-1 1 VIAL, SINGLE-DOSE in 1 BOX (70121-1236-1) > 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/20ML (1MG/ML)
Approval Date:Nov 6, 2017TE:APRLD:No

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