← FDA DRUG APPROVALS

FDA ANDA · ANDA211369

LEVOTHYROXINE SODIUM

Sponsor: ANI PHARMS

APPLICATION
ANDA211369
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-28
LATEST ACTION
2023-05-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.2MG · CAPSULE · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.15MG · CAPSULE · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.137MG · CAPSULE · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.112MG · CAPSULE · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.075MG · CAPSULE · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.175MG · CAPSULE · ORAL

Approval history

2023-05-02Manufacturing (CMC) · Supplement 5 · unknownAP
2020-10-28UNKNOWN · Original · standard — Letter ↗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 →