Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215922
Company: RUBICON RESEARCH

Products on ANDA 215922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IVERMECTIN	IVERMECTIN	3MG	TABLET;ORAL	Prescription	AB	No	No
IVERMECTIN	IVERMECTIN	6MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215922

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215922Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215922

IVERMECTIN

TABLET;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IVERMECTIN	IVERMECTIN	3MG	TABLET;ORAL	Prescription	No	AB	204154	EDENBRIDGE PHARMS
IVERMECTIN	IVERMECTIN	3MG	TABLET;ORAL	Prescription	No	AB	218805	EPIC PHARMA LLC
IVERMECTIN	IVERMECTIN	3MG	TABLET;ORAL	Prescription	No	AB	215922	RUBICON RESEARCH
IVERMECTIN	IVERMECTIN	3MG	TABLET;ORAL	Prescription	No	AB	218324	SENORES PHARMS
IVERMECTIN	IVERMECTIN	3MG	TABLET;ORAL	Prescription	No	AB	216863	ZYDUS LIFESCIENCES
STROMECTOL	IVERMECTIN	3MG	TABLET;ORAL	Prescription	Yes	AB	050742	MERCK SHARP DOHME