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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021292

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NDA 021292 describes EUTHYROX, which is a drug marketed by Provell and is included in one NDA. It is available from one supplier. Additional details are available on the EUTHYROX profile page.

The generic ingredient in EUTHYROX is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 021292
Tradename:EUTHYROX
Applicant:Provell
Ingredient:levothyroxine sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021292
Suppliers and Packaging for NDA: 021292
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EUTHYROX levothyroxine sodium TABLET;ORAL 021292 NDA Provell Pharmaceuticals, LLC 72305-025 72305-025-30 2 BLISTER PACK in 1 CARTON (72305-025-30) > 15 TABLET in 1 BLISTER PACK
EUTHYROX levothyroxine sodium TABLET;ORAL 021292 NDA Provell Pharmaceuticals, LLC 72305-050 72305-050-30 2 BLISTER PACK in 1 CARTON (72305-050-30) > 15 TABLET in 1 BLISTER PACK

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:May 31, 2002TE:AB2RLD: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:May 31, 2002TE:AB2RLD: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:May 31, 2002TE:AB2RLD:No

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