Last Updated: November 8, 2026

Details for New Drug Application (NDA): 021301

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NDA 021301 describes LEVOXYL, which is a drug marketed by King Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LEVOXYL profile page.

The generic ingredient in LEVOXYL 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 021301

Tradename:	LEVOXYL
Applicant:	King Pharms
Ingredient:	levothyroxine sodium
Patents:	0

Pharmacology for NDA: 021301

Suppliers and Packaging for NDA: 021301

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301	NDA	Pfizer Laboratories Div Pfizer Inc	60793-850	60793-850-01	100 TABLET in 1 BOTTLE (60793-850-01)
LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301	NDA	Pfizer Laboratories Div Pfizer Inc	60793-850	60793-850-10	1000 TABLET in 1 BOTTLE (60793-850-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:	May 25, 2001	TE:	AB1,AB3	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:	May 25, 2001	TE:	AB1,AB3	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:	May 25, 2001	TE:	AB1,AB3	RLD:	Yes

Expired US Patents for NDA 021301

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-004	May 25, 2001	6,555,581	⤷ Start Trial
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-009	May 25, 2001	7,067,148	⤷ Start Trial
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-007	May 25, 2001	7,101,569	⤷ Start Trial
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-006	May 25, 2001	7,101,569	⤷ Start Trial
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-002	May 25, 2001	6,555,581	⤷ Start Trial
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-003	May 25, 2001	7,067,148	⤷ Start Trial
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-008	May 25, 2001	7,101,569	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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