APPLICATION
ANDA087062
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-16
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ORPHENADRINE CITRATEDiscontinued
ORPHENADRINE CITRATE 30MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 21AP
1999-02-02Manufacturing (CMC) · Supplement 20AP
1996-12-04Manufacturing (CMC) · Supplement 19AP
1996-02-14Manufacturing (CMC) · Supplement 18AP
1991-05-10Manufacturing (CMC) · Supplement 15AP
1991-05-10Manufacturing (CMC) · Supplement 13AP
1991-05-10Manufacturing (CMC) · Supplement 14AP
1990-10-04Labeling · Supplement 17AP
1990-05-22Labeling · Supplement 16AP
1988-10-05Manufacturing (CMC) · Supplement 11AP
1988-10-05Manufacturing (CMC) · Supplement 12AP
1987-09-28Manufacturing (CMC) · Supplement 7AP
1987-09-28Manufacturing (CMC) · Supplement 5AP
1986-05-01Manufacturing (CMC) · Supplement 4AP
1983-11-07Manufacturing (CMC) · Supplement 2AP
1983-06-16Manufacturing (CMC) · Supplement 1AP
1981-07-16OriginalAP
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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