Drugs@FDA: FDA-Approved Drugs
Company: VALIDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUMEX | BUMETANIDE | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
02/28/1983 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/29/2002 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/018226s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm | |
10/29/2002 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm | |
02/24/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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01/06/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/04/1997 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/18/1997 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/10/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
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10/21/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/11/1993 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/01/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/01/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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10/14/1988 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/10/1987 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/10/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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01/05/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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09/06/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
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08/08/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/03/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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07/03/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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12/14/1984 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/01/1984 | SUPPL-2 | Efficacy |
Label is not available on this site. |
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11/22/1983 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/29/2002 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/018226s025lbl.pdf | |
10/29/2002 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf |