APPLICATION
NDA008278
TYPE
NDA
ORIGINAL APPROVAL
1952-01-30
LATEST ACTION
1999-04-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
REGITINE · ReferenceDiscontinued
PHENTOLAMINE MESYLATE 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1999-04-29Manufacturing (CMC) · Supplement 20 · priorityAP
1999-02-05Manufacturing (CMC) · Supplement 19 · priorityAP
1998-11-05Manufacturing (CMC) · Supplement 18 · priorityAP
1998-10-20Manufacturing (CMC) · Supplement 17 · priorityAP
1992-01-09Manufacturing (CMC) · Supplement 16 · priorityAP
1986-04-14Manufacturing (CMC) · Supplement 15 · priorityAP
1985-05-13Labeling · Supplement 11AP
1983-07-27Manufacturing (CMC) · Supplement 12 · priorityAP
1983-07-21Manufacturing (CMC) · Supplement 13 · priorityAP
1981-09-09Manufacturing (CMC) · Supplement 10 · priorityAP
1981-02-18Manufacturing (CMC) · Supplement 9 · priorityAP
1980-01-07Manufacturing (CMC) · Supplement 8 · priorityAP
1977-04-12Labeling · Supplement 6AP
1977-02-11Manufacturing (CMC) · Supplement 7 · priorityAP
1977-02-11Manufacturing (CMC) · Supplement 5 · priorityAP
1952-01-30Type 1 - New Molecular Entity · Original · priorityAP
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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