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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214253

LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
100MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOTHYROXINE SODIUM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MCG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214253
Product Number: 001
Approval Date: May 17, 2021
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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