APPLICATION
NDA019854
TYPE
NDA
ORIGINAL APPROVAL
1978-11-08
LATEST ACTION
1994-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEPEN · ReferencePrescription
PENICILLAMINE 250MG · TABLET · ORAL
Approval history
1994-08-17Manufacturing (CMC) · Supplement 6 · standardAP
1993-10-22Manufacturing (CMC) · Supplement 5 · standardAP
1990-06-07Manufacturing (CMC) · Supplement 4 · standardAP
1988-12-22Labeling · Supplement 3AP
1986-11-10Manufacturing (CMC) · Supplement 2 · standardAP
1978-11-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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