Last Updated: August 8, 2026

Details for New Drug Application (NDA): 215809

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NDA 215809 describes ERMEZA, which is a drug marketed by Mylan and is included in one NDA. There is one patent protecting this drug. Additional details are available on the ERMEZA profile page.

The generic ingredient in ERMEZA is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 215809

Tradename:	ERMEZA
Applicant:	Mylan
Ingredient:	levothyroxine sodium
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	150MCG/5ML
Approval Date:	Apr 29, 2022	TE:		RLD:	Yes
Patent:	9,345,772	Patent Expiration:	Feb 27, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

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