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| DOBUTAMINE HYDROCHLORIDE | EQ 12.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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. |