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FDA NDA · NDA050805

ORACEA

doxycycline

Sponsor: GALDERMA LABS LP

APPLICATION
NDA050805
TYPE
NDA
ORIGINAL APPROVAL
2006-05-26
LATEST ACTION
2025-04-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ORACEA · ReferencePrescription
DOXYCYCLINE 40MG · CAPSULE · ORAL

Approval history

2025-04-02Labeling · Supplement 20 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 11 · standard — Label ↗AP
2015-09-03Manufacturing (CMC) · Supplement 10 · standardAP
2015-06-24Manufacturing (CMC) · Supplement 9 · standardAP
2013-07-25Labeling · Supplement 8 · standard — Label ↗AP
2012-11-07Labeling · Supplement 7 · standard — Label ↗AP
2010-05-13Labeling · Supplement 2 · standard — Label ↗AP
2006-05-26Type 3 - New Dosage Form · Original · standard — Label ↗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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