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 eight 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-one 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

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	021342-001	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-004	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-005	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-008	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-007	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-009	Mar 1, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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