Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207308
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
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 |
---|---|---|---|---|---|---|---|
01/08/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/21/2019 | SUPPL-1 | Labeling-Package Insert |
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 | SANDOZ |
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 | 209063 | BRECKENRIDGE |
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 PHARMS |
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 | SANDOZ |
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 | 209063 | BRECKENRIDGE |
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 PHARMS |
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 | SANDOZ |
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 | 209063 | BRECKENRIDGE |
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 PHARMS |