Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017807
Company: NEW RIVER
Company: NEW RIVER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROFERDEX | FERRIC OXYHYDROXIDE | EQ 50MG IRON/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 |
|---|---|---|---|---|---|---|---|
| 03/26/1981 | 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 |
|---|---|---|---|---|---|
| 03/06/1989 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1986 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/03/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/19/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/17/1986 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 01/04/1984 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/05/1982 | SUPPL-1 | Labeling |
Label is not available on this site. |