Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016729
Company: MALLINCKRODT
Company: MALLINCKRODT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FERROUS CITRATE FE 59 | FERROUS CITRATE, FE-59 | 25uCi/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 |
---|---|---|---|---|---|---|---|
12/17/1973 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/24/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/10/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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08/23/1977 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1977 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |