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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 213623


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NDA 213623 describes DAPTOMYCIN, which is a drug marketed by Accord Hlthcare, Aspiro, Be Pharms, 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 twenty-eight NDAs. It is available from twenty-five suppliers. There are three 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-seven suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 213623
Tradename:DAPTOMYCIN
Applicant:Meitheal
Ingredient:daptomycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 213623
Medical Subject Heading (MeSH) Categories for 213623
Suppliers and Packaging for NDA: 213623
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 213623 ANDA Meitheal Pharmaceuticals Inc. 71288-016 71288-016-15 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-016-15) / 10 mL in 1 VIAL, SINGLE-DOSE
DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 213623 ANDA Meitheal Pharmaceuticals Inc. 71288-016 71288-016-95 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-016-95) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Jun 29, 2021TE:APRLD:No

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