U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 206977

Expand all

TIROSINT-SOL (LEVOTHYROXINE SODIUM)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Back to Top