Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017725
Company: MALLINCKRODT
Company: MALLINCKRODT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM PERTECHNETATE TC 99M | TECHNETIUM TC-99M SODIUM PERTECHNETATE | 10-60mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INJECTION, ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/30/1977 | 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 |
---|---|---|---|---|---|
09/09/1986 | SUPPL-10 | Efficacy-New Indication |
Label is not available on this site. |
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07/20/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/19/1989 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/20/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
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10/05/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/18/1983 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/14/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/10/1979 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |