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FDA NDA · NDA209521

SEYSARA

sarecycline hydrochloride

Sponsor: ALMIRALL

APPLICATION
NDA209521
TYPE
NDA
ORIGINAL APPROVAL
2018-10-01
LATEST ACTION
2023-03-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SEYSARA · ReferencePrescription
SARECYCLINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SEYSARA · ReferencePrescription
SARECYCLINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
SEYSARA · ReferencePrescription
SARECYCLINE HYDROCHLORIDE EQ 60MG BASE · TABLET · ORAL

Approval history

2023-03-30Labeling · Supplement 16 · standard — Letter ↗AP
2023-03-30Labeling · Supplement 15 · standard — Letter ↗AP
2020-06-01Labeling · Supplement 7 · standard — Label ↗AP
2019-04-09Labeling · Supplement 1 · standard — Label ↗AP
2018-10-01Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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