Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202122
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENTECAVIR | ENTECAVIR | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| ENTECAVIR | ENTECAVIR | 1MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/26/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202122Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/16/2020 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/13/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/13/2019 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |