Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012154
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UREAPHIL | 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 |
|---|---|---|---|---|---|---|---|
| 10/05/1966 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 04/03/2002 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12154slr023ltr.pdf |
| 10/28/1985 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/24/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/29/1980 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/02/1977 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |