Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216966
Company: GLAND

Products on ANDA 216966

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANGIOTENSIN ll ACETATE	ANGIOTENSIN II ACETATE	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216966

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216966Orig1s000TA_ltr.pdf

Therapeutic Equivalents for ANDA 216966

ANGIOTENSIN ll ACETATE

SOLUTION;INTRAVENOUS; EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANGIOTENSIN ll ACETATE	ANGIOTENSIN II ACETATE	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216966	GLAND
GIAPREZA	ANGIOTENSIN II ACETATE	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209360	LA JOLLA PHARMA