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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 205366

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NDA 205366 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-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 205366

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Ph Health
Ingredient:	levothyroxine sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	200MCG/VIAL
Approval Date:	Dec 7, 2015	TE:		RLD:	No

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