Drugs@FDA: FDA-Approved Drugs
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. |
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04/03/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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06/06/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
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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. |
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09/08/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
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04/28/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/22/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
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06/24/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/29/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/29/1980 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/11/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/29/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/02/1977 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/01/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |