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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021402

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NDA 021402 describes SYNTHROID, which is a drug marketed by Abbvie and is included in one NDA. It is available from five suppliers. Additional details are available on the SYNTHROID profile page.

The generic ingredient in SYNTHROID 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 021402
Tradename:SYNTHROID
Applicant:Abbvie
Ingredient:levothyroxine sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021402
Ingredient-typeThyroxine
Suppliers and Packaging for NDA: 021402
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNTHROID levothyroxine sodium TABLET;ORAL 021402 NDA AbbVie Inc. 0074-3727 0074-3727-19 1000 TABLET in 1 BOTTLE (0074-3727-19)
SYNTHROID levothyroxine sodium TABLET;ORAL 021402 NDA AbbVie Inc. 0074-3727 0074-3727-71 4 BLISTER PACK in 1 CARTON (0074-3727-71) > 7 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:Jul 24, 2002TE:AB1,AB2RLD: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:Jul 24, 2002TE:AB1,AB2RLD: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:Jul 24, 2002TE:AB1,AB2RLD:Yes

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