Last Updated: November 13, 2026

Details for New Drug Application (NDA): 213256

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NDA 213256 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, Alembic, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in twenty-two NDAs. It is available from thirty-eight suppliers. There are eight 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 is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 213256

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Ani Pharms
Ingredient:	levothyroxine sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.088MG
Approval Date:	Jan 6, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.1MG
Approval Date:	Jan 6, 2021	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	0.125MG
Approval Date:	Jan 6, 2021	TE:		RLD:	No

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