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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Boehringer Ingelheim

Last Updated: December 10, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204029

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NDA 204029 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 eight 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. Ten suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
Summary for 204029
Applicant:Abon Pharms Llc
Pharmacology for NDA: 204029
Suppliers and Packaging for NDA: 204029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 204029 ANDA Fresenius-Kabi 63323-572 63323-572-70 1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) > 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/20ML (1MG/ML)
Approval Date:May 9, 2017TE:APRLD:No

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