INDOCIN SR
Summary
FDA approved INDOCIN SR by ZYLA. NDA (New Drug) approval (Labeling) on 2024-11-21. CAPSULE, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
NDA018185-59
Action Date
2024-11-21
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
INDOCIN SR, CAPSULE, EXTENDED RELEASE, ORAL. Application: NDA018185
Company
Context & Analysis
Frequently Asked Questions
How often does ZYLA have FDA actions?
This is the only FDA action we have on record for ZYLA in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA018185-59" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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