Drugs@FDA: FDA-Approved Drugs
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL | Discontinued | None | No | No |
BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 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 |
---|---|---|---|---|---|---|---|
03/06/2015 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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06/02/2023 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/20/2024 | SUPPL-21 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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12/16/2022 | SUPPL-20 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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11/16/2022 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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06/17/2022 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/03/2022 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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06/17/2022 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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06/13/2022 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/27/2021 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/07/2019 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/31/2018 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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02/01/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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01/31/2018 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/31/2018 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/23/2017 | SUPPL-5 | REMS-Modified |
Label is not available on this site. |
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12/16/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/07/2016 | SUPPL-2 | REMS-Proposal |
Label is not available on this site. |