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Last Updated: March 19, 2024

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. Forty-eight 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:RXDosage:TABLET;ORALStrength0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:Mar 1, 2002TE:AB1,AB2,AB3RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:Mar 1, 2002TE:AB1,AB2,AB3RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:Mar 1, 2002TE:AB1,AB2,AB3RLD:No

Expired US Patents for NDA 021342

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
Cediprof Inc LEVO-T levothyroxine sodium TABLET;ORAL 021342-005 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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