← FDA DRUG APPROVALS

FDA NDA · NDA021137

LEVOLET

Sponsor: GENUS LIFESCIENCES

APPLICATION
NDA021137
TYPE
NDA
ORIGINAL APPROVAL
2003-06-06
LATEST ACTION
2022-08-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVOLETPrescription
LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

Approval history

2022-08-05Efficacy · Supplement 5 · standard — Letter ↗AP
2021-12-17Efficacy · Supplement 4 · standard — Label ↗AP
2021-12-17Efficacy · Supplement 2 · standard — Label ↗AP
2021-12-17Efficacy · Supplement 3 · standard — Label ↗AP
2003-06-06Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →