APPLICATION
NDA009838
TYPE
NDA
ORIGINAL APPROVAL
1955-03-24
LATEST ACTION
2015-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RESERPINE · ReferenceDiscontinued
RESERPINE 0.25MG · TABLET · ORAL
RESERPINE · ReferenceDiscontinued
RESERPINE 0.1MG · TABLET · ORAL
Approval history
2015-06-17Manufacturing (CMC) · Supplement 40AP
1999-12-08Manufacturing (CMC) · Supplement 35AP
1999-09-07Manufacturing (CMC) · Supplement 34AP
1996-11-06Labeling · Supplement 33 · standardAP
1996-03-15Manufacturing (CMC) · Supplement 32AP
1955-03-24Type 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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