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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205533
Company: APOTEX

Products on ANDA 205533

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205533Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 205533

BORTEZOMIB

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS; 3.5MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	205533	APOTEX
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	213823	BAXTER HLTHCARE CORP
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	202963	DR REDDYS
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	212825	EUGIA PHARMA
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209659	FRESENIUS KABI USA
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	208460	HOSPIRA
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	215011	JIANGSU HANSOH PHARM
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	212958	MEITHEAL
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209622	MSN
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	208392	PHARMASCIENCE INC
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	210824	QILU PHARM HAINAN
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	203654	SANDOZ
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	211898	WAVERLEY PHARMA INC
BORTEZOMIB	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	210204	ZYDUS PHARMS
VELCADE	BORTEZOMIB	3.5MG/VIAL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	021602	TAKEDA PHARMS USA

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