Last Updated: November 8, 2026

Details for New Drug Application (NDA): 210632

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NDA 210632 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 210632

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	levothyroxine sodium
Patents:	4

Pharmacology for NDA: 210632

Suppliers and Packaging for NDA: 210632

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOTHYROXINE SODIUM	levothyroxine sodium	SOLUTION;INTRAVENOUS	210632	NDA	Fresenius Kabi USA, LLC	63323-885	63323-885-10	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-10) / 5 mL in 1 VIAL, SINGLE-DOSE
LEVOTHYROXINE SODIUM	levothyroxine sodium	SOLUTION;INTRAVENOUS	210632	NDA	Fresenius Kabi USA, LLC	63323-885	63323-885-14	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-14) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MCG/5ML (20MCG/ML)
Approval Date:	Apr 11, 2019	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Dec 1, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Dec 1, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Dec 1, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

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