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Details for New Drug Application (NDA): 021342

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NDA 021342 describes LEVO-T, which is a drug marketed by Alara Pharm and is included in one NDA. It is available from thirteen suppliers. There is one patent protecting this drug. Additional details are available on the LEVO-T profile page.

The generic ingredient in LEVO-T is levothyroxine sodium. There are nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for NDA: 021342

Tradename:
LEVO-T
Applicant:
Alara Pharm
Ingredient:
levothyroxine sodium
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021342

Ingredient-typeThyroxine

Suppliers and Packaging for NDA: 021342

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVO-T
levothyroxine sodium
TABLET;ORAL 021342 NDA Sandoz Inc. 0781-5180 0781-5180-01 100 TABLET in 1 BOTTLE (0781-5180-01)
LEVO-T
levothyroxine sodium
TABLET;ORAL 021342 NDA Sandoz Inc. 0781-5180 0781-5180-10 1000 TABLET in 1 BOTTLE (0781-5180-10)

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:Mar 1, 2002TE:AB1,AB2,AB3RLD:No
Patent:6,399,101Patent Expiration:Mar 30, 2020Product Flag?Substance Flag?Delist Request?

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:Mar 1, 2002TE:AB1,AB2,AB3RLD:No
Patent:6,399,101Patent Expiration:Mar 30, 2020Product Flag?Substance Flag?Delist Request?

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:Mar 1, 2002TE:AB1,AB2,AB3RLD:No
Patent:6,399,101Patent Expiration:Mar 30, 2020Product Flag?Substance Flag?Delist Request?


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