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FDA NDA · NDA206977

TIROSINT SOL

levothyroxine sodium

Sponsor: IBSA

APPLICATION
NDA206977
TYPE
NDA
ORIGINAL APPROVAL
2016-12-15
LATEST ACTION
2023-11-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 137MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 62.5MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 112MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 37.5MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 88MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 175MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 50MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 13MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 125MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 44MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 100MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 200MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 75MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 150MCG/ML · SOLUTION · ORAL
TIROSINT-SOL · ReferencePrescription
LEVOTHYROXINE SODIUM 25MCG/ML · SOLUTION · ORAL

Approval history

2023-11-16Labeling · Supplement 12 · standard — Label ↗AP
2023-11-16Labeling · Supplement 10 · standard — Label ↗AP
2021-01-13Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2017-02-24Labeling · Supplement 1 · standard — Label ↗AP
2016-12-15Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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