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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219167
Company: GLAND

Products on ANDA 219167

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BORTEZOMIB	BORTEZOMIB	1MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	No	No
BORTEZOMIB	BORTEZOMIB	2.5MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219167

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219167Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 219167

BORTEZOMIB

POWDER;INTRAVENOUS, SUBCUTANEOUS; 1MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BORTEZOMIB	BORTEZOMIB	1MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	219167	GLAND
BORTEZOMIB	BORTEZOMIB	1MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	209191	HOSPIRA

POWDER;INTRAVENOUS, SUBCUTANEOUS; 2.5MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BORTEZOMIB	BORTEZOMIB	2.5MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	219167	GLAND
BORTEZOMIB	BORTEZOMIB	2.5MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	209191	HOSPIRA

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