Drugs@FDA: FDA-Approved Drugs
Company: PHARMALUCENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PYROLITE | TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES 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 |
---|---|---|---|---|---|---|---|
11/19/1976 | 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 |
---|---|---|---|---|---|
05/02/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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02/07/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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12/17/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/23/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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06/13/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/26/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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05/02/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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06/10/1986 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
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11/17/1983 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/31/1983 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/04/1982 | SUPPL-6 | Labeling |
Label is not available on this site. |
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08/11/1980 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/02/1983 | SUPPL-1 | Efficacy |
Label is not available on this site. |