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Levothyroxine Sodium Anhydrous

FDA Drug Profile — Levothyroxine Sodium

Drug Details

Generic Name
Levothyroxine Sodium Anhydrous
Brand Names
Levothyroxine Sodium
Application Number
ANDA208749
Sponsor
Sagent Pharmaceuticals
NDC Codes
3
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
LEVOTHYROXINE SODIUM ANHYDROUS

Indications and Usage

1 INDICATIONS AND USAGE Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied. Levothyroxine Sodium is an L-thyroxine product. Levothyroxine (T 4 ) Sodium for Injection is indicated for the treatment of myxedema coma. ( 1 ) Important Limitations of Use: The relative bioavailability of this drug has not been established. Use caution when converting patients from oral to intravenous levothyroxine.