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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210632

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LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
100MCG/5ML (20MCG/ML)
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOTHYROXINE SODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MCG/5ML (20MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210632
Product Number: 001
Approval Date: Apr 11, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
200MCG/5ML (40MCG/ML)
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOTHYROXINE SODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MCG/5ML (40MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210632
Product Number: 002
Approval Date: Apr 11, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
500MCG/5ML (100MCG/ML)
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOTHYROXINE SODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 500MCG/5ML (100MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210632
Product Number: 003
Approval Date: Apr 11, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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