Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078035
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CABERGOLINE | CABERGOLINE | 0.5MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/21/2008 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/078035Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/16/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |