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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209526
Company: MSN

Products on ANDA 209526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARFILZOMIB	CARFILZOMIB	60MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No
CARFILZOMIB	CARFILZOMIB	30MG	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No
CARFILZOMIB	CARFILZOMIB	60MG	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2026	ORIG-2	Tentative Approval		STANDARD		Label is not available on this site.
07/20/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209526

CARFILZOMIB

POWDER;INTRAVENOUS; 60MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARFILZOMIB	CARFILZOMIB	60MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	209422	DR REDDYS
CARFILZOMIB	CARFILZOMIB	60MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	209526	MSN
KYPROLIS	CARFILZOMIB	60MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	202714	ONYX PHARMS AMGEN

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