Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018904
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UROLOGIC G IN PLASTIC CONTAINER | CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE | 3.24GM/100ML;380MG/100ML;430MG/100ML | SOLUTION;IRRIGATION | 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 |
|---|---|---|---|---|---|---|---|
| 05/07/2008 | 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 |
|---|---|---|---|---|---|
| 03/03/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/10/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/18/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/22/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/24/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/18/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/25/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |