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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 217495

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NDA 217495 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Ani Pharms, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Onesource Specialty, Ph Health, Piramal Critical, Xiromed, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in twenty-one NDAs. It is available from thirty-eight suppliers. There are seven patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEVOTHYROXINE SODIUM profile page.

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

Summary for 217495

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Xiromed
Ingredient:	levothyroxine sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MCG/VIAL
Approval Date:	Nov 29, 2024	TE:	AP	RLD:	No

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