← FDA DRUG APPROVALS

FDA NDA · NDA022382

SPRIX

ketorolac tromethamine

Sponsor: COSETTE

APPLICATION
NDA022382
TYPE
NDA
ORIGINAL APPROVAL
2010-05-14
LATEST ACTION
2024-11-21
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

SPRIX · ReferencePrescription
KETOROLAC TROMETHAMINE 15.75MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2024-11-21Labeling · Supplement 22 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 21 · standard — Letter ↗AP
2018-01-22Labeling · Supplement 18 · standard — Label ↗AP
2016-06-10Manufacturing (CMC) · Supplement 15 · standardAP
2016-05-09Labeling · Supplement 12 · standard — Label ↗AP
2016-05-09Labeling · Supplement 13 · standard — Label ↗AP
2015-05-11Manufacturing (CMC) · Supplement 11 · standardAP
2014-04-21Labeling · Supplement 9 · standard — Label ↗AP
2013-07-29Manufacturing (CMC) · Supplement 8 · standardAP
2013-07-02Manufacturing (CMC) · Supplement 7 · standardAP
2010-05-14Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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