Drugs@FDA: FDA-Approved Drugs
Company: I3 PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZAROXOLYN | METOLAZONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ZAROXOLYN | METOLAZONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ZAROXOLYN | METOLAZONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/27/1973 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 05/24/2019 | SUPPL-43 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017386s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017386Orig1s043ltr.pdf | |
| 03/30/2015 | SUPPL-40 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/017386Orig1s040.pdf |
| 11/22/2013 | SUPPL-39 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/017386Orig1s039.pdf |
| 08/19/2003 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017386s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17386slr036,19532slr016ltr.pdf | |
| 10/29/2002 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17386slr034,19532slr015ltr.pdf |
| 04/15/2002 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/2001 | SUPPL-32 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17386s32lbl.pdf | |
| 10/18/2001 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/1999 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/14/1997 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/07/1997 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/23/1995 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 05/04/1994 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 01/13/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/10/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/09/1988 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1987 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1988 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/12/1985 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/07/1984 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/1984 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1987 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/18/1983 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/15/1983 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1983 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1982 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/02/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1989 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/03/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/11/1977 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/25/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/25/1978 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/24/2019 | SUPPL-43 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017386s043lbl.pdf |
| 08/19/2003 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017386s036lbl.pdf | |
| 08/10/2001 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17386s32lbl.pdf |