Drugs@FDA: FDA-Approved Drugs
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/2011/079075s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079075s000ltr.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 |
---|---|---|---|---|---|
08/28/2024 | SUPPL-18 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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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-Package Insert, Labeling-Medication Guide |
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. |