Last Updated: June 27, 2026

Details for New Drug Application (NDA): 212250

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NDA 212250 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-five 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-six suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

Summary for 212250

Tradename:	DAPTOMYCIN
Applicant:	Hisun Pharm Hangzhou
Ingredient:	daptomycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 212250

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL
Approval Date:	Apr 21, 2021	TE:	AP	RLD:	No

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