APPLICATION
NDA016931
TYPE
NDA
ORIGINAL APPROVAL
1973-02-28
LATEST ACTION
2010-01-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
R-GENE 10 · ReferencePrescription
ARGININE HYDROCHLORIDE 10GM/100ML · INJECTABLE · INJECTION
Approval history
2000-04-11Manufacturing (CMC) · Supplement 27 · priorityAP
1995-03-15Labeling · Supplement 26 · standardAP
1993-03-17Manufacturing (CMC) · Supplement 25 · priorityAP
1991-10-09Manufacturing (CMC) · Supplement 24 · priorityAP
1990-02-28Labeling · Supplement 23AP
1989-10-24Manufacturing (CMC) · Supplement 22 · priorityAP
1986-03-05Labeling · Supplement 21AP
1985-07-29Labeling · Supplement 20AP
1985-02-19Labeling · Supplement 18AP
1984-05-09Manufacturing (CMC) · Supplement 19 · priorityAP
1982-01-11Manufacturing (CMC) · Supplement 17 · priorityAP
1980-06-30Labeling · Supplement 14AP
1975-10-01Manufacturing (CMC) · Supplement 6 · priorityAP
1975-08-25Manufacturing (CMC) · Supplement 5 · priorityAP
1973-02-28Type 5 - New Formulation or New Manufacturer · 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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