← FDA DRUG APPROVALS

FDA NDA · NDA021301

LEVOXYL

levothyroxine sodium

Sponsor: KING PHARMS

APPLICATION

NDA021301

TYPE

NDA

ORIGINAL APPROVAL

2001-05-25

LATEST ACTION

2018-12-20

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription, Discontinued

Products

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferenceDiscontinued

LEVOTHYROXINE SODIUM 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

LEVOXYL · ReferencePrescription

LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

Approval history

2018-12-20Labeling · Supplement 38 · standard — Label ↗AP

2014-11-05Manufacturing (CMC) · Supplement 37 · standardAP

2014-05-06Manufacturing (CMC) · Supplement 35 · standardAP

2012-12-14Manufacturing (CMC) · Supplement 34 · standardAP

2011-03-21Manufacturing (CMC) · Supplement 27 — Label ↗AP

2009-09-01Supplement · Supplement 28 · standard — Review ↗AP

2008-07-08Labeling · Supplement 26 · standard — Letter ↗AP

2005-03-08Labeling · Supplement 14 · standard — Letter ↗AP

2003-07-23Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP

2002-12-31Manufacturing (CMC) · Supplement 3 · standardAP

2002-07-17Labeling · Supplement 2 · standard — Letter ↗AP

2002-04-03Manufacturing (CMC) · Supplement 1 · standardAP

2001-05-25Type 5 - New Formulation or New Manufacturer · 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.

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