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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212513

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NDA 212513 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-seven 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-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

Summary for 212513

Tradename:	DAPTOMYCIN
Applicant:	Be Pharms
Ingredient:	daptomycin
Patents:	0

Pharmacology for NDA: 212513

Medical Subject Heading (MeSH) Categories for 212513

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 212513

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	212513	ANDA	BE Pharmaceuticals Inc.	71839-107	71839-107-01	1 VIAL, SINGLE-DOSE in 1 CARTON (71839-107-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL
Approval Date:	Jun 26, 2019	TE:	AP	RLD:	No

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