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FDA NDA · NDA022556

CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION

carbinoxamine maleate

Sponsor: AYTU

APPLICATION
NDA022556
TYPE
NDA
ORIGINAL APPROVAL
2013-03-28
LATEST ACTION
2026-03-10
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

KARBINAL ER · ReferencePrescription
CARBINOXAMINE MALEATE 4MG/5ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2026-03-10Labeling · Supplement 15 · standard — Label ↗AP
2021-03-25Labeling · Supplement 6 · standard — Label ↗AP
2016-05-12Manufacturing (CMC) · Supplement 3 · standardAP
2015-12-02Manufacturing (CMC) · Supplement 2 · standardAP
2015-09-10Manufacturing (CMC) · Supplement 1 · standardAP
2013-03-28Type 3 - New Dosage Form · Original · standard — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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