Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215210
Company: ZYDUS LIFESCIENCES

Products on ANDA 215210

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 215210

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2023	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215210

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