Last Updated: September 28, 2026

Details for New Drug Application (NDA): 213396

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NDA 213396 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, Hikma, Hisun Pharm Hangzhou, Hospira, Maia Pharms Inc, 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-one NDAs. It is available from twenty-six suppliers. There are five patents protecting this drug. Additional details are available on the DAPTOMYCIN profile page.

The generic ingredient in DAPTOMYCIN is daptomycin. There is one drug master file entry for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

Summary for 213396

Tradename:	DAPTOMYCIN
Applicant:	Fresenius Kabi Usa
Ingredient:	daptomycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 213396

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	350MG/VIAL
Approval Date:	Aug 1, 2024	TE:		RLD:	No

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