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Last Updated: November 30, 2023

Details for New Drug Application (NDA): 021342

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NDA 021342 describes LEVO-T, which is a drug marketed by Cediprof Inc and is included in one NDA. It is available from eleven suppliers. Additional details are available on the LEVO-T profile page.

The generic ingredient in LEVO-T is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 021342

Tradename:	LEVO-T
Applicant:	Cediprof Inc
Ingredient:	levothyroxine sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021342

Suppliers and Packaging for NDA: 021342

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVO-T	levothyroxine sodium	TABLET;ORAL	021342	NDA AUTHORIZED GENERIC	Lannett Company, Inc	0527-3280	0527-3280-43	1000 TABLET in 1 BOTTLE (0527-3280-43)
LEVO-T	levothyroxine sodium	TABLET;ORAL	021342	NDA AUTHORIZED GENERIC	Lannett Company, Inc	0527-3280	0527-3280-46	90 TABLET in 1 BOTTLE (0527-3280-46)

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:	Mar 1, 2002	TE:	AB1,AB2,AB3	RLD:	No

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:	Mar 1, 2002	TE:	AB1,AB2,AB3	RLD:	No

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:	Mar 1, 2002	TE:	AB1,AB2,AB3	RLD:	No

Expired US Patents for NDA 021342

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-010	Mar 1, 2002	⤷ Try a Trial	⤷ Try a Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-007	Mar 1, 2002	⤷ Try a Trial	⤷ Try a Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-008	Mar 1, 2002	⤷ Try a Trial	⤷ Try a Trial
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-001	Mar 1, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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