Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207338
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET;SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET;SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.3MG BASE | TABLET;SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET;SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET;SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET;SUBLINGUAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/17/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207338Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/28/2024 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/14/2023 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/08/2022 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/17/2022 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/03/2021 | SUPPL-2 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/23/2020 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |