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FDA ANDA · ANDA090097

LIOTHYRONINE SODIUM

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA090097
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-20
LATEST ACTION
2019-12-17
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

2019-12-17Labeling · Supplement 13 · standardAP
2009-03-20OriginalReviewAP
VIEW ON DRUGS@FDA ↗

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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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