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Generated: January 23, 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, Hospira Inc, Sagent Pharms, Teva Parenteral, and Xellia Pharms Aps, and is included in five 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 63323-871-15 1 VIAL in 1 CARTON (63323-871-15) > 10 mL in 1 VIAL

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Chinese Patent Office

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