← FDA DRUG APPROVALS

FDA NDA · NDA022198

SANCUSO

granisetron

Sponsor: APOTEX

APPLICATION
NDA022198
TYPE
NDA
ORIGINAL APPROVAL
2008-09-12
LATEST ACTION
2024-09-16
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

SANCUSO · ReferencePrescription
GRANISETRON 3.1MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2024-09-16Labeling · Supplement 23 · standard — Letter ↗AP
2022-12-06Manufacturing (CMC) · Supplement 19 — Letter ↗AP
2020-04-30Labeling · Supplement 20 · standard — Letter ↗AP
2017-09-13Labeling · Supplement 16 · standard — Label ↗AP
2015-09-28Labeling · Supplement 3 · unknown — Label ↗AP
2014-09-18Labeling · Supplement 12 · 901 required — Letter ↗AP
2014-07-15Manufacturing (CMC) · Supplement 11 · standardAP
2013-11-19Manufacturing (CMC) · Supplement 10 · standardAP
2013-02-14Manufacturing (CMC) · Supplement 9 · standardAP
2011-09-23Labeling · Supplement 5 · standard — Label ↗AP
2008-09-12Type 2 - New Active Ingredient · Original · standard — 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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