Details for New Drug Application (NDA): 206077

NDA 206077 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, Hisun Pharm Hangzhou, Hospira, 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 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-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

Summary for 206077

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

Pharmacology for NDA: 206077

Medical Subject Heading (MeSH) Categories for 206077

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 206077

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	206077	ANDA	Fresenius Kabi USA, LLC	63323-371	63323-371-10	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-371-10) / 10 mL in 1 VIAL, SINGLE-DOSE
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	206077	ANDA	Fresenius Kabi USA, LLC	63323-371	63323-371-19	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-371-19) / 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:	Apr 11, 2018	TE:	AP	RLD:	No

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