Drugs@FDA: FDA-Approved Drugs
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/SPRAY | SPRAY, METERED;NASAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/08/2001 | ORIG-1 | Approval |
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-35 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/08/2019 | SUPPL-31 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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09/21/2018 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-28 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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03/07/2017 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/16/2016 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/17/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/26/2002 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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08/26/2002 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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08/26/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
BUTORPHANOL TARTRATE
SPRAY, METERED;NASAL; 1MG/SPRAY
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 075499 | APOTEX |
BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 075824 | HIKMA |
BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 075759 | RISING |