APPLICATION
NDA009509
TYPE
NDA
ORIGINAL APPROVAL
1954-09-29
LATEST ACTION
2001-02-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ARAMINE · ReferenceDiscontinued
METARAMINOL BITARTRATE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1998-02-19Manufacturing (CMC) · Supplement 25 · priorityAP
1998-01-09Manufacturing (CMC) · Supplement 23 · priorityAP
1998-01-09Manufacturing (CMC) · Supplement 24 · priorityAP
1995-12-05Manufacturing (CMC) · Supplement 22 · priorityAP
1992-01-15Manufacturing (CMC) · Supplement 21 · priorityAP
1987-12-22Labeling · Supplement 19 · priorityAP
1987-12-22Labeling · Supplement 15 · priorityAP
1985-08-27Manufacturing (CMC) · Supplement 17 · priorityAP
1984-10-11Manufacturing (CMC) · Supplement 16 · priorityAP
1982-10-22Manufacturing (CMC) · Supplement 14 · priorityAP
1981-11-03Manufacturing (CMC) · Supplement 12 · priorityAP
1981-07-14Manufacturing (CMC) · Supplement 13 · priorityAP
1980-02-05Manufacturing (CMC) · Supplement 11 · priorityAP
1978-10-30Labeling · Supplement 10 · priorityAP
1954-09-29Type 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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