APPLICATION
ANDA205622
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-20
LATEST ACTION
2025-01-22
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
RIVASTIGMINEPrescription
RIVASTIGMINE 9.5MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
RIVASTIGMINEPrescription
RIVASTIGMINE 13.3MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
RIVASTIGMINEPrescription
RIVASTIGMINE 4.6MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2025-01-22Labeling · Supplement 11 · standardAP
2019-04-16Labeling · Supplement 1 · standardAP
2018-06-20UNKNOWN · 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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