Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079075
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.1MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.2MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.4MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.6MG BASE | TABLET;BUCCAL, SUBLINGUAL | Discontinued | None | No | No |
| FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.8MG BASE | TABLET;BUCCAL, 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 |
|---|---|---|---|---|---|---|---|
| 01/07/2011 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079075s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079075s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/079075Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 08/17/2022 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 12/03/2021 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 12/23/2020 | SUPPL-14 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 09/07/2017 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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| 04/12/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/08/2016 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 01/08/2016 | SUPPL-10 | REMS-Proposal |
Label is not available on this site. |
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| 05/03/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/03/2015 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |