Drugs@FDA: FDA-Approved Drugs
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOBUTREX | DOBUTAMINE HYDROCHLORIDE | EQ 12.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/18/1978 | 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 |
|---|---|---|---|---|---|
| 07/23/2002 | SUPPL-37 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17820slr037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/17-820_Dobutrex.cfm |
| 07/29/1998 | SUPPL-36 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17820-s036_doubtrex.pdf |
| 01/08/1997 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/06/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 11/09/1995 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1996 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/10/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/30/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 04/20/1994 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 02/09/1993 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/01/1993 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/20/1990 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 04/26/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 12/07/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 04/18/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 06/23/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/21/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/27/1987 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 01/21/1987 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/27/1987 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/21/1987 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/07/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/1986 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/25/1985 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/24/1983 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 02/24/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/08/1986 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/17/1981 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/03/1981 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/13/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/12/1978 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 09/12/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |