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Last Updated: April 13, 2026

Details for New Drug Application (NDA): 212022

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NDA 212022 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 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-seven suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

Summary for 212022

Tradename:	DAPTOMYCIN
Applicant:	Hengrui Pharma
Ingredient:	daptomycin
Patents:	0

Pharmacology for NDA: 212022

Medical Subject Heading (MeSH) Categories for 212022

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 212022

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	212022	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9378	0143-9378-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9378-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL
Approval Date:	Aug 22, 2019	TE:		RLD:	No

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