Details for New Drug Application (NDA): 213623

NDA 213623 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 213623

Tradename:	DAPTOMYCIN
Applicant:	Meitheal
Ingredient:	daptomycin
Patents:	0

Pharmacology for NDA: 213623

Medical Subject Heading (MeSH) Categories for 213623

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 213623

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213623	ANDA	Meitheal Pharmaceuticals Inc.	71288-016	71288-016-95	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-016-95) / 10 mL in 1 VIAL, SINGLE-DOSE
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213623	ANDA	Meitheal Pharmaceuticals Inc.	71288-016	71288-016-91	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-016-91) / 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 29, 2021	TE:	AP	RLD:	No

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