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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 214253

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NDA 214253 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 214253

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Hikma
Ingredient:	levothyroxine sodium
Patents:	1

Pharmacology for NDA: 214253

Suppliers and Packaging for NDA: 214253

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOTHYROXINE SODIUM	levothyroxine sodium	SOLUTION;INTRAVENOUS	214253	NDA	Hikma Pharmaceuticals USA Inc.	24201-002	24201-002-01	1 VIAL, SINGLE-DOSE in 1 CARTON (24201-002-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MCG/ML
Approval Date:	May 17, 2021	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Jul 20, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

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