Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207104
Company: SAGENT PHARMS INC

Products on ANDA 207104

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207104

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/19/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/19/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/19/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/19/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207104

DAPTOMYCIN

POWDER;INTRAVENOUS; 500MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211961	ACCORD HLTHCARE
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	216413	ASPIRO
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212513	BE PHARMS
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	208375	DR REDDYS
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213171	EUGIA PHARMA
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206077	FRESENIUS KABI USA
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215890	HAINAN POLY PHARM
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215215	HANGZHOU ZHONGMEI
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212022	HENGRUI PHARMA
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212250	HISUN PHARM HANGZHOU
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213623	MEITHEAL
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213966	MYLAN
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	205037	MYLAN LABS LTD
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	215316	QILU PHARM HAINAN
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207104	SAGENT PHARMS INC
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	091039	TEVA PHARMS USA
DAPTOMYCIN	DAPTOMYCIN	500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206005	XELLIA PHARMS APS