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FDA Approval

Tirosint

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
IBSA Pharma Inc.
DUNS: 081215551
Effective Date
November 30, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine(137 ug in 1 mL)

Products15

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tirosint SOL

Product Details

NDC Product Code
71858-0145
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 137 ug in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Tirosint SOL

Product Details

NDC Product Code
71858-0150
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 150 ug in 1 mL

Tirosint SOL

Product Details

NDC Product Code
71858-0155
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 175 ug in 1 mL

Tirosint SOL

Product Details

NDC Product Code
71858-0130
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 100 ug in 1 mL

Tirosint SOL

Product Details

NDC Product Code
71858-0113
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 44 ug in 1 mL

Tirosint SOL

Product Details

NDC Product Code
71858-0120
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 75 ug in 1 mL

Tirosint SOL

Product Details

NDC Product Code
71858-0112
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 37.5 ug in 1 mL

Tirosint SOL

Product Details

NDC Product Code
71858-0160
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 200 ug in 1 mL

Tirosint SOL

Product Details

NDC Product Code
71858-0115
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 50 ug in 1 mL

Tirosint SOL

Product Details

NDC Product Code
71858-0110
Application Number
NDA206977
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 30, 2023
Code: 9J765S329GClass: ACTIRQuantity: 25 ug in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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