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FDA ANDA · ANDA209063
RIVASTIGMINE TRANSDERMAL SYSTEM
rivastigmine
Sponsor: BRECKENRIDGE
APPLICATION
ANDA209063
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-26
LATEST ACTION
2019-11-26
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
RIVASTIGMINEPrescription
RIVASTIGMINE 13.3MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
RIVASTIGMINEPrescription
RIVASTIGMINE 4.6MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
RIVASTIGMINEPrescription
RIVASTIGMINE 9.5MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2019-11-26UNKNOWN · 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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