Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216774
Company: TEVA PHARMS INC

• Medication Guide

Products on NDA 216774

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALVAIZ	ELTROMBOPAG CHOLINE	EQ 9MG BASE	TABLET;ORAL	Prescription	None	Yes	No
ALVAIZ	ELTROMBOPAG CHOLINE	EQ 18MG BASE	TABLET;ORAL	Prescription	None	Yes	No
ALVAIZ	ELTROMBOPAG CHOLINE	EQ 36MG BASE	TABLET;ORAL	Prescription	None	Yes	No
ALVAIZ	ELTROMBOPAG CHOLINE	EQ 54MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216774

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2023	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216774s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216774Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216774Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/15/2026	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216774s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216774Orig1s006ltr.pdf

Labels for NDA 216774

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/15/2026	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216774s006lbl.pdf
11/29/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216774s000lbl.pdf