← FDA DRUG APPROVALS

FDA ANDA · ANDA076752

LEVOTHYROXINE SODIUM

Sponsor: MERCK KGAA

APPLICATION
ANDA076752
TYPE
ANDA
ORIGINAL APPROVAL
2005-06-16
LATEST ACTION
2008-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.15MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.112MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.088MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.2MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.05MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.175MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.125MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.1MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.3MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.075MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.025MG · TABLET · ORAL

Approval history

2008-10-31Labeling · Supplement 6AP
2006-09-19Labeling · Supplement 2AP
2005-06-16OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →