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FDA ANDA · ANDA091382

LIOTHYRONINE SODIUM

Sponsor: SUN PHARM

APPLICATION
ANDA091382
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-20
LATEST ACTION
2021-05-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LIOTHYRONINE SODIUMPrescription
LIOTHYRONINE SODIUM EQ 0.05MG BASE · TABLET · ORAL
LIOTHYRONINE SODIUMPrescription
LIOTHYRONINE SODIUM EQ 0.005MG BASE · TABLET · ORAL
LIOTHYRONINE SODIUMPrescription
LIOTHYRONINE SODIUM EQ 0.025MG BASE · TABLET · ORAL

Approval history

2021-05-17Labeling · Supplement 2 · standardAP
2016-04-20Original — 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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