Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017698
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STERILE UREA | UREA | 40GM/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/1976 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | 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 |
|---|---|---|---|---|---|
| 03/08/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/03/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/25/1980 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/02/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/22/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |