Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206318
Company: ZYDUS NOVELTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/04/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

RIVASTIGMINE

FILM, EXTENDED RELEASE;TRANSDERMAL; 4.6MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXELON RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 022083 NOVARTIS
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204403 ALVOGEN
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 207308 AMNEAL PHARMS
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 205622 MYLAN TECHNOLOGIES
RIVASTIGMINE RIVASTIGMINE 4.6MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206318 ZYDUS NOVELTECH INC

FILM, EXTENDED RELEASE;TRANSDERMAL; 9.5MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXELON RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 022083 NOVARTIS
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204403 ALVOGEN
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 207308 AMNEAL PHARMS
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 205622 MYLAN TECHNOLOGIES
RIVASTIGMINE RIVASTIGMINE 9.5MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206318 ZYDUS NOVELTECH INC

FILM, EXTENDED RELEASE;TRANSDERMAL; 13.3MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXELON RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 022083 NOVARTIS
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204403 ALVOGEN
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 207308 AMNEAL PHARMS
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 205622 MYLAN TECHNOLOGIES
RIVASTIGMINE RIVASTIGMINE 13.3MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206318 ZYDUS NOVELTECH INC

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