← FDA DRUG APPROVALS

FDA NDA · NDA022159

ORAVERSE

phentolamine mesylate

Sponsor: SEPTODONT HOLDING

APPLICATION
NDA022159
TYPE
NDA
ORIGINAL APPROVAL
2008-05-09
LATEST ACTION
2016-03-18
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ORAVERSE · ReferencePrescription
PHENTOLAMINE MESYLATE 0.4MG/1.7ML · INJECTABLE · INJECTION

Approval history

2016-03-18Efficacy · Supplement 11 · standard — Pediatric Medical Review ↗AP
2016-01-07Manufacturing (CMC) · Supplement 12 · standardAP
2015-01-26Manufacturing (CMC) · Supplement 10 · standardAP
2015-01-26Manufacturing (CMC) · Supplement 9 · standardAP
2015-01-05Manufacturing (CMC) · Supplement 8 · standardAP
2014-04-09Manufacturing (CMC) · Supplement 7 · standardAP
2014-01-09Manufacturing (CMC) · Supplement 5 · standardAP
2013-09-09Manufacturing (CMC) · Supplement 6 · standardAP
2008-05-09Type 3 - New Dosage Form · Original · standard — Summary 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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