Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017098
Company: MALLINCKRODT
Company: MALLINCKRODT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SELENOMETHIONINE SE 75 | SELENOMETHIONINE SE-75 | 100uCi/ML | 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 |
---|---|---|---|---|---|---|---|
05/07/1973 | 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 |
---|---|---|---|---|---|
03/13/1984 | SUPPL-11 | Labeling |
Label is not available on this site. |
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10/05/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/07/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/01/1979 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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08/23/1977 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |