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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213551
Company: GLAND

Products on ANDA 213551

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CANGRELOR	CANGRELOR	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213551

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213551Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 213551

CANGRELOR

POWDER;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CANGRELOR	CANGRELOR	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	213551	GLAND
KENGREAL	CANGRELOR	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	204958	CHIESI

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