Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078247
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 2MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
04/29/2009 | 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 |
---|---|---|---|---|---|
01/16/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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01/16/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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09/15/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |