Drugs@FDA: FDA-Approved Drugs
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STADOL | BUTORPHANOL TARTRATE | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| STADOL PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| STADOL PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/22/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/05/2001 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/25/1999 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 03/13/1998 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 03/13/1998 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 04/16/1993 | SUPPL-50 | Labeling |
Label is not available on this site. |
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| 04/16/1993 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 05/01/1992 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 09/19/1990 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/12/1988 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/04/1987 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 01/14/1987 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/20/1986 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/05/1987 | SUPPL-39 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 01/10/1985 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/22/1985 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/19/1984 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 06/07/1984 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 06/07/1984 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 05/09/1984 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 04/16/1984 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 04/04/1984 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 10/24/1984 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/07/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/17/1984 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 09/07/1983 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 04/20/1983 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/20/1983 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/26/1982 | SUPPL-22 | Efficacy-New Patient Population |
Label is not available on this site. |
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| 05/14/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/14/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/02/1981 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/03/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/04/1987 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/04/1987 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/15/1979 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/07/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/20/1979 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/20/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/20/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 09/14/1978 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/14/1978 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/14/1978 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/14/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |