Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210019
Company: TEVA PHARMS USA

Products on ANDA 210019

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IVERMECTIN	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210019

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210019Orig1s000TA_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/09/2020	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 210019

IVERMECTIN

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IVERMECTIN	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	No	AB	210225	PADAGIS ISRAEL
IVERMECTIN	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	No	AB	210019	TEVA PHARMS USA
IVERMECTIN	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	No	AB	215210	ZYDUS LIFESCIENCES
SOOLANTRA	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	Yes	AB	206255	GALDERMA LABS LP