Drugs@FDA: FDA-Approved Drugs
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HIPREX | METHENAMINE HIPPURATE | 1GM | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/09/1976 | 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 |
|---|---|---|---|---|---|
| 12/01/2017 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017681s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017681Orig1s018ltr.pdf |
| 08/01/2016 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/2005 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17681s014ltr.pdf | |
| 06/10/2004 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17681slr013ltr.pdf | |
| 08/09/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1988 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/03/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1984 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/26/1982 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/25/1980 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/25/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/27/1978 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1978 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/01/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017681s018lbl.pdf |
| 11/21/2005 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf | |
| 06/10/2004 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf |
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