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Serving 500+ biopharmaceutical companies globally:

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Generated: July 28, 2017

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 twenty-four 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-two suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for NDA: 021210

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
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)

Summary 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

Summary 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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Novartis
AstraZeneca
QuintilesIMS
Cerilliant
Cantor Fitzgerald
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UBS
Fuji
McKesson
Mallinckrodt

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