Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208711
Company: NOVARTIS

Products on NDA 208711

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EGATEN	TRICLABENDAZOLE	250MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208711

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208711Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2022	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208711s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208711Orig1s002ltr.pdf

Labels for NDA 208711

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208711s002lbl.pdf
02/13/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf