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Last Updated: December 12, 2024

Details for New Drug Application (NDA): 205366

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NDA 205366 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Maia Pharms Inc, Piramal Critical, 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 nineteen NDAs. It is available from thirty-six 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-one suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 205366

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Endo Operations
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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