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Generated: November 12, 2018

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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 twenty-three 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
Ingredient-typeThyroxine
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. 0527-1341 0527-1341-01 100 TABLET in 1 BOTTLE, PLASTIC (0527-1341-01)
UNITHROID levothyroxine sodium TABLET;ORAL 021210 NDA Lannett Company, Inc. 0527-1341 0527-1341-10 1000 TABLET in 1 BOTTLE, PLASTIC (0527-1341-10)

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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