Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212667
Company: ACCORD HLTHCARE

Products on ANDA 212667

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPTOMYCIN	DAPTOMYCIN	350MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212667

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212667Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2026	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212667

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