Product Details for NDA 206977
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
13MCG/ML
Marketing Status: Prescription
25MCG/ML
Marketing Status: Prescription
37.5MCG/ML
Marketing Status: Prescription
44MCG/ML
Marketing Status: Prescription
50MCG/ML
Marketing Status: Prescription
62.5MCG/ML
Marketing Status: Prescription
75MCG/ML
Marketing Status: Prescription
88MCG/ML
Marketing Status: Prescription
100MCG/ML
Marketing Status: Prescription
112MCG/ML
Marketing Status: Prescription
125MCG/ML
Marketing Status: Prescription
137MCG/ML
Marketing Status: Prescription
150MCG/ML
Marketing Status: Prescription
175MCG/ML
Marketing Status: Prescription
200MCG/ML
Marketing Status: Prescription
13MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 13MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 001
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 13MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 001
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
25MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 25MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 002
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 25MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 002
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
37.5MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 37.5MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 013
Approval Date: Jan 13, 2021
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 37.5MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 013
Approval Date: Jan 13, 2021
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
44MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 44MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 014
Approval Date: Jan 13, 2021
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 44MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 014
Approval Date: Jan 13, 2021
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
50MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 50MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 003
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 50MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 003
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
62.5MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 62.5MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 015
Approval Date: Jan 13, 2021
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 62.5MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 015
Approval Date: Jan 13, 2021
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
75MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 75MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 004
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 75MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 004
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
88MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 88MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 005
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 88MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 005
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
100MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 100MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 006
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 100MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 006
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
112MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 112MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 007
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 112MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 007
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
125MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 125MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 008
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 125MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 008
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
137MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 137MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 009
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 137MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 009
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
150MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 150MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 010
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 150MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 010
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
175MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 175MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 011
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
TIROSINT-SOL (LEVOTHYROXINE SODIUM)
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 175MCG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N206977
Product Number: 011
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
200MCG/ML
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 200MCG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N206977
Product Number: 012
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: TIROSINT-SOL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 200MCG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N206977
Product Number: 012
Approval Date: Dec 15, 2016
Applicant Holder Full Name: IBSA INSTITUT BIOCHIMIQUE SA
Marketing Status: Prescription
Patent and Exclusivity Information