APPLICATION
NDA007942
TYPE
NDA
ORIGINAL APPROVAL
1951-06-08
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SUS-PHRINE SULFITE FREEDiscontinued
EPINEPHRINE 1.5MG/AMP · INJECTABLE · INJECTION
SUS-PHRINE SULFITE FREEDiscontinued
EPINEPHRINE 5MG/ML · INJECTABLE · INJECTION
Approval history
2007-12-07Efficacy · Supplement 1AP
2007-12-07Labeling · Supplement 12AP
2007-12-07Labeling · Supplement 9AP
1999-02-05Labeling · Supplement 16 · standardAP
1998-10-07Manufacturing (CMC) · Supplement 17 · standardAP
1995-02-08Manufacturing (CMC) · Supplement 15 · standardAP
1993-12-20Labeling · Supplement 14AP
1990-01-19Manufacturing (CMC) · Supplement 11 · standardAP
1986-11-19Manufacturing (CMC) · Supplement 6 · standardAP
1985-10-16Manufacturing (CMC) · Supplement 8 · standardAP
1984-12-06Manufacturing (CMC) · Supplement 7 · standardAP
1983-10-26Labeling · Supplement 3AP
1983-10-26Manufacturing (CMC) · Supplement 2 · standardAP
1983-10-26Labeling · Supplement 5AP
1951-06-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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