ORACEA (DOXYCYCLINE)
Summary
FDA approved ORACEA (DOXYCYCLINE) by GALDERMA LABS LP. NDA (New Drug) approval (Labeling) on 2025-04-02. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA050805-20
Action Date
2025-04-02
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ORACEA (generic: DOXYCYCLINE), CAPSULE, ORAL. Application: NDA050805
Company
Context & Analysis
GALDERMA LABS LP has 3 FDA actions in our database.
Frequently Asked Questions
How often does GALDERMA LABS LP have FDA actions?
GALDERMA LABS LP has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA050805-20" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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