APPLICATION
ANDA040327
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-15
LATEST ACTION
2010-03-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ORPHENADRINE CITRATEPrescription
ORPHENADRINE CITRATE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2010-03-30Labeling · Supplement 12AP
2002-05-08Manufacturing (CMC) · Supplement 3AP
2001-05-30Manufacturing (CMC) · Supplement 2AP
2000-02-15Manufacturing (CMC) · Supplement 1AP
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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