APPLICATION
ANDA040463
TYPE
ANDA
ORIGINAL APPROVAL
2003-03-04
LATEST ACTION
2019-07-23
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ORPHENADRINE CITRATEPrescription
ORPHENADRINE CITRATE 30MG/ML · INJECTABLE · INJECTION
Approval history
2019-07-23Manufacturing (CMC) · Supplement 10AP
2008-08-11Labeling · Supplement 5AP
2003-03-04OriginalAP
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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