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FDA NDA · NDA022348

CALDOLOR

ibuprofen

Sponsor: APOTEX

APPLICATION
NDA022348
TYPE
NDA
ORIGINAL APPROVAL
2009-06-11
LATEST ACTION
2026-01-23
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

CALDOLOR · ReferencePrescription
IBUPROFEN 800MG/8ML (100MG/ML) · SOLUTION · INTRAVENOUS
CALDOLOR · ReferencePrescription
IBUPROFEN 800MG/200ML (4MG/ML) · SOLUTION · INTRAVENOUS
CALDOLORDiscontinued
IBUPROFEN 400MG/4ML (100MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-01-23Efficacy · Supplement 28 · standard — Letter ↗AP
2024-11-21Labeling · Supplement 27 · standard — Letter ↗AP
2023-05-11Efficacy · Supplement 24 · standard — Label ↗AP
2022-12-06Labeling · Supplement 20 · standard — Letter ↗AP
2021-11-19Efficacy · Supplement 21 · standard — Label ↗AP
2021-04-28Labeling · Supplement 18 · standard — Letter ↗AP
2019-07-22Labeling · Supplement 14 · standard — Letter ↗AP
2019-01-25Manufacturing (CMC) · Supplement 13AP
2016-05-09Labeling · Supplement 10 · standard — Label ↗AP
2015-11-20Efficacy · Supplement 5 · standard — Pediatric Clinical Pharmacology Review ↗AP
2015-03-09Manufacturing (CMC) · Supplement 4 · priorityAP
2015-01-27Labeling · Supplement 3 · standard — Letter ↗AP
2014-01-14Manufacturing (CMC) · Supplement 2 · priorityAP
2009-06-11Type 5 - New Formulation or New Manufacturer · Original · priority — 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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