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Last Updated: September 25, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206077


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NDA 206077 describes DAPTOMYCIN, which is a drug marketed by Accord Hlthcare, Be Pharms, Dr Reddys, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Hong Kong, Hospira Inc, Jiangsu Hengrui Med, Mylan Labs Ltd, Sagent Pharms Inc, Teva Pharms Usa, and Xellia Pharms Aps, and is included in nineteen NDAs. It is available from fifteen suppliers. There are two patents protecting this drug. Additional details are available on the DAPTOMYCIN profile page.

The generic ingredient in DAPTOMYCIN is daptomycin. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 206077
Tradename:DAPTOMYCIN
Applicant:Fresenius Kabi Usa
Ingredient:daptomycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206077
Medical Subject Heading (MeSH) Categories for 206077
Suppliers and Packaging for NDA: 206077
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 206077 ANDA Fresenius Kabi USA, LLC 63323-371 63323-371-19 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-371-19) > 10 mL in 1 VIAL, SINGLE-DOSE
DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 206077 ANDA Fresenius Kabi USA, LLC 63323-371 63323-371-10 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-371-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Apr 11, 2018TE:APRLD:No

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