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Last Updated: April 15, 2026

Details for New Drug Application (NDA): 208385

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NDA 208385 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 208385

Tradename:	DAPTOMYCIN
Applicant:	Sagent Pharms Inc
Ingredient:	daptomycin
Patents:	0

Pharmacology for NDA: 208385

Medical Subject Heading (MeSH) Categories for 208385

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 208385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	208385	NDA	Sagent Pharmaceuticals	25021-179	25021-179-15	1 VIAL in 1 CARTON (25021-179-15) / 7 mL in 1 VIAL
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	208385	NDA	Sagent Pharmaceuticals	25021-179	25021-179-16	10 VIAL in 1 CARTON (25021-179-16) / 7 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	350MG/VIAL
Approval Date:	Sep 12, 2017	TE:	AP	RLD:	Yes

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