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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208385
Company: SAGENT PHARMS INC

Products on NDA 208385

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208385Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208385Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208385Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208385s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208385Orig1s008ltr.pdf
02/07/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208385s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208385Orig1s007ltr.pdf
04/03/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208385s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208385Orig1s005ltr.pdf
08/30/2018	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208385s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208385Orig1001ltr.pdf

Labels for NDA 208385

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208385s008lbl.pdf
02/07/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208385s007lbl.pdf
04/03/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208385s005lbl.pdf
08/30/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208385s001lbl.pdf
09/12/2017	ORIG-1	Approval	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208385Orig1s000lbl.pdf

Therapeutic Equivalents for NDA 208385

DAPTOMYCIN

POWDER;INTRAVENOUS; 350MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	212667	ACCORD HLTHCARE
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	216445	ASPIRO
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213425	BE PHARMS
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211403	DR REDDYS
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213786	MEITHEAL
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	208385	SAGENT PHARMS INC

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