← FDA DRUG APPROVALS

FDA NDA · NDA208845

ZILRETTA

triamcinolone acetonide extended-release injectable suspension

Sponsor: PACIRA PHARMS INC

APPLICATION
NDA208845
TYPE
NDA
ORIGINAL APPROVAL
2017-10-06
LATEST ACTION
2024-12-03
ROUTE
INTRA-ARTICULAR
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ZILRETTA · ReferencePrescription
TRIAMCINOLONE ACETONIDE 32MG/VIAL · FOR SUSPENSION, EXTENDED RELEASE · INTRA-ARTICULAR

Approval history

2024-12-03Labeling · Supplement 21 · standard — Letter ↗AP
2024-09-05Labeling · Supplement 19 · standard — Letter ↗AP
2020-12-02Labeling · Supplement 11 · standard — Letter ↗AP
2019-12-23Efficacy · Supplement 7 · standard — Letter ↗AP
2017-10-06Type 5 - New Formulation or New Manufacturer · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →