APPLICATION
ANDA084779
TYPE
ANDA
ORIGINAL APPROVAL
1982-03-15
LATEST ACTION
2007-04-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ORPHENADRINE CITRATEPrescription
ORPHENADRINE CITRATE 30MG/ML · INJECTABLE · INJECTION
Approval history
2007-04-16Labeling · Supplement 19AP
1999-02-19Manufacturing (CMC) · Supplement 17AP
1999-02-02Manufacturing (CMC) · Supplement 16AP
1997-06-20Manufacturing (CMC) · Supplement 15AP
1996-04-03Manufacturing (CMC) · Supplement 14AP
1995-08-16Manufacturing (CMC) · Supplement 13AP
1994-12-12Manufacturing (CMC) · Supplement 12AP
1990-09-27Labeling · Supplement 11AP
1988-12-23Bioequivalence · Supplement 6AP
1988-11-18Manufacturing (CMC) · Supplement 10AP
1988-11-18Manufacturing (CMC) · Supplement 9AP
1986-05-28Manufacturing (CMC) · Supplement 4AP
1984-02-17Manufacturing (CMC) · Supplement 1AP
1982-03-15OriginalAP
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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