Drugs@FDA: FDA-Approved Drugs
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TECHNETIUM TC 99M MPI MDP | TECHNETIUM TC-99M MEDRONATE KIT | N/A | INJECTABLE;INJECTION | Discontinued | None | No | No |
TECHNETIUM TC 99M MPI MDP | TECHNETIUM TC-99M MEDRONATE KIT | N/A | INJECTABLE;INJECTION | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
06/26/1979 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
09/05/2007 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018141s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018141s029_ltr.pdf | |
11/25/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/10/2001 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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09/29/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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11/12/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/12/1994 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/01/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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10/31/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
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02/17/1989 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/12/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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01/30/1985 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/23/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/09/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/09/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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11/06/1980 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/09/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/31/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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06/09/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/12/1989 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/05/2007 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018141s029lbl.pdf |