Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021210

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NDA 021210 describes UNITHROID, which is a drug marketed by Stevens J and is included in one NDA. It is available from nineteen suppliers. Additional details are available on the UNITHROID profile page.

The generic ingredient in UNITHROID 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 021210
Tradename:UNITHROID
Applicant:Stevens J
Ingredient:levothyroxine sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021210
Suppliers and Packaging for NDA: 021210
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UNITHROID levothyroxine sodium TABLET;ORAL 021210 NDA Lannett Company, Inc. 0527-1370 0527-1370-01 100 TABLET in 1 BOTTLE, PLASTIC (0527-1370-01)
UNITHROID levothyroxine sodium TABLET;ORAL 021210 NDA Lannett Company, Inc. 0527-1371 0527-1371-01 100 TABLET in 1 BOTTLE, PLASTIC (0527-1371-01)

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:Aug 21, 2000TE:AB1,AB2,AB3RLD:Yes

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:Aug 21, 2000TE:AB1,AB2,AB3RLD:Yes

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:Aug 21, 2000TE:AB1,AB2,AB3RLD:Yes

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