Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210720
Company: TARO

Products on ANDA 210720

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IVERMECTIN	IVERMECTIN	0.5%	LOTION;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210720

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210720Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2021	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

IVERMECTIN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

LOTION;TOPICAL; 0.5%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
IVERMECTIN	IVERMECTIN	0.5%	LOTION;TOPICAL	Over-the-counter	No	210720	TARO
SKLICE	IVERMECTIN	0.5%	LOTION;TOPICAL	Over-the-counter	Yes	202736	ARBOR PHARMS LLC