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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021924

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TIROSINT (LEVOTHYROXINE SODIUM)
0.013MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.013MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 013
Approval Date: Aug 1, 2007
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.025MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.025MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 002
Approval Date: Oct 13, 2006
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.0375MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.0375MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 014
Approval Date: Jun 22, 2022
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.044MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.044MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 015
Approval Date: Jun 22, 2022
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.05MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.05MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 003
Approval Date: Oct 13, 2006
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.0625MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.0625MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 016
Approval Date: Jun 22, 2022
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.075MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.075MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 004
Approval Date: Oct 13, 2006
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.088MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.088MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 010
Approval Date: Oct 2, 2009
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.1MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 005
Approval Date: Oct 13, 2006
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.112MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.112MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 008
Approval Date: Oct 2, 2009
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.125MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 006
Approval Date: Oct 13, 2006
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.137MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.137MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 009
Approval Date: Oct 2, 2009
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.15MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 007
Approval Date: Oct 13, 2006
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.175MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.175MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021924
Product Number: 011
Approval Date: Apr 25, 2017
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
TIROSINT (LEVOTHYROXINE SODIUM)
0.2MG
Marketing Status: Prescription
Active Ingredient: LEVOTHYROXINE SODIUM
Proprietary Name: TIROSINT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021924
Product Number: 012
Approval Date: Apr 25, 2017
Applicant Holder Full Name: INSTITUT BIOCHIMIQUE SA (IBSA)
Marketing Status:  Prescription
Patent and Exclusivity Information
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