Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204403
Company: ALVOGEN
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIVASTIGMINE | RIVASTIGMINE | 4.6MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| RIVASTIGMINE | RIVASTIGMINE | 9.5MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| RIVASTIGMINE | RIVASTIGMINE | 13.3MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/03/2015 | ORIG-2 | Approval |
Label is not available on this site. |
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| 08/31/2015 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204403Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204403Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/204403Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/04/2020 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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| 12/04/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/24/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/24/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |