Drugs@FDA: FDA-Approved Drugs
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MPI DMSA KIDNEY REAGENT | TECHNETIUM TC-99M SUCCIMER KIT | N/A **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
05/18/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
02/28/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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11/22/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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11/24/2003 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17944slr018ltr.pdf |
11/25/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/10/2001 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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09/29/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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11/12/1999 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/16/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/15/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/15/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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02/17/1989 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/17/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/12/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/30/1985 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/23/1986 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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05/27/1983 | SUPPL-2 | Labeling |
Label is not available on this site. |
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04/10/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |