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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 215890


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NDA 215890 describes DAPTOMYCIN, which is a drug marketed by Accord Hlthcare, Aspiro, Be Pharms, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hangzhou Zhongmei, Hengrui Pharma, Hisun Pharm Hangzhou, Hospira, Meitheal, Mylan, Mylan Labs Ltd, Qilu Pharm Hainan, Sagent Pharms Inc, Teva Pharms Usa, Xellia Pharms Aps, and Baxter Hlthcare Corp, and is included in thirty NDAs. It is available from twenty-six suppliers. There are four 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 215890
Tradename:DAPTOMYCIN
Applicant:Hainan Poly Pharm
Ingredient:daptomycin
Patents:0
Pharmacology for NDA: 215890
Medical Subject Heading (MeSH) Categories for 215890
Suppliers and Packaging for NDA: 215890
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 215890 ANDA Hainan Poly Pharm., Co., Ltd. 14335-120 14335-120-01 20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01)
DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 215890 ANDA Slate Run Pharmaceuticals, LLC 70436-033 70436-033-80 20 mL in 1 VIAL, SINGLE-DOSE (70436-033-80)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Aug 18, 2022TE:APRLD:No

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