Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204154
Company: EDENBRIDGE PHARMS

Products on ANDA 204154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IVERMECTIN	IVERMECTIN	3MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2014	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204154Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204154Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/19/2024	SUPPL-10	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 204154

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204154Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 204154

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
STROMECTOL	IVERMECTIN	3MG	TABLET;ORAL	Prescription	Yes	AB	050742	MERCK SHARP DOHME