Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017059
Company: MALLINCKRODT
Company: MALLINCKRODT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TECHNECOLL | TECHNETIUM TC-99M SULFUR COLLOID KIT | N/A | SOLUTION;INJECTION, ORAL | 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 |
---|---|---|---|---|---|---|---|
09/30/1974 | 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 |
---|---|---|---|---|---|
02/10/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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09/09/1985 | SUPPL-10 | Efficacy |
Label is not available on this site. |
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09/06/1984 | SUPPL-9 | Efficacy |
Label is not available on this site. |
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10/19/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/07/1979 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/23/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1977 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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07/14/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |