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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202857

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NDA 202857 describes DAPTOMYCIN, which is a drug marketed by Crane Pharms Llc, Fresenius Kabi Usa, Hospira Inc, Mylan Labs Ltd, Teva Pharms Usa, Sagent Pharms, and Xellia Pharms Aps, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the DAPTOMYCIN profile page.

The generic ingredient in DAPTOMYCIN is daptomycin. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 202857
Applicant:Hospira Inc
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 202857
Medical Subject Heading (MeSH) Categories for 202857
Suppliers and Packaging for NDA: 202857
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 202857 ANDA Hospira, Inc. 0409-0106 N 0409-0106-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Sep 12, 2014TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice

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