Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016666
Company: MALLINCKRODT
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HIPPURAN I 131 | IODOHIPPURATE SODIUM I-131 | 0.25mCi/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 |
|---|---|---|---|---|---|---|---|
| 05/24/1968 | 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 |
|---|---|---|---|---|---|
| 05/15/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/16/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/07/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/23/1977 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1977 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1975 | SUPPL-6 | Labeling |
Label is not available on this site. |