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. |
||
| 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. |
||
| 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. |