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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206005

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NDA 206005 describes DAPTOMYCIN, which is a drug marketed by Crane Pharms Llc, Fresenius Kabi Usa, Hospira Inc, Teva Pharms Usa, Sagent Pharms, and Xellia Pharms Aps, and is included in six 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 206005
Applicant:Crane Pharms Llc
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 206005
Medical Subject Heading (MeSH) Categories for 206005
Suppliers and Packaging for NDA: 206005
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 206005 ANDA Fresenius Kabi USA, LLC 63323-871 E 63323-871-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Jun 15, 2016TE:APRLD:No

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