APPLICATION
NDA013055
TYPE
NDA
ORIGINAL APPROVAL
1960-10-02
LATEST ACTION
2008-02-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NORFLEX · ReferenceDiscontinued
ORPHENADRINE CITRATE 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-06-04Manufacturing (CMC) · Supplement 19 · priorityAP
2001-06-06Manufacturing (CMC) · Supplement 18 · priorityAP
2000-11-22Manufacturing (CMC) · Supplement 17 · priorityAP
1992-09-24Manufacturing (CMC) · Supplement 16 · priorityAP
1991-09-03Manufacturing (CMC) · Supplement 15 · priorityAP
1985-08-22Manufacturing (CMC) · Supplement 13 · priorityAP
1978-11-29Manufacturing (CMC) · Supplement 10 · priorityAP
1978-03-24Manufacturing (CMC) · Supplement 9 · priorityAP
1975-11-03Labeling · Supplement 8AP
1960-10-02Type 3 - New Dosage Form · 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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