Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202231

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LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
100MCG/VIAL
Marketing Status: Prescription

Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOTHYROXINE SODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 100MCG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N202231
Product Number: 001
Approval Date: Jun 24, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
200MCG/VIAL
Marketing Status: Prescription

Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOTHYROXINE SODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 200MCG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N202231
Product Number: 002
Approval Date: Jun 24, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
500MCG/VIAL
Marketing Status: Prescription

Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: LEVOTHYROXINE SODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 500MCG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N202231
Product Number: 003
Approval Date: Jun 24, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information