Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209063
Company: BRECKENRIDGE
Company: BRECKENRIDGE
| 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 |
|---|---|---|---|---|---|---|---|
| 11/26/2019 | 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 | 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 |