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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

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. There are three patents protecting this drug. Additional details are available on the LEVOXYL profile page.

The generic ingredient in LEVOXYL 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 021301
Tradename:LEVOXYL
Applicant:King Pharms
Ingredient:levothyroxine sodium
Patents:3
Formulation / Manufacturing:see details
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)
Paragraph IV (Patent) Challenges for 021301
Tradename Dosage Ingredient NDA Submissiondate
LEVOXYL TABLET;ORAL levothyroxine sodium 021301

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 25, 2001TE:AB1,AB3RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 15, 2022Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 15, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 2, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USE OF ADMINISTERING LEVOTHYROXINE

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