Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020729
Company: UCB INC
Company: UCB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UNIRETIC | HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE | 12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| UNIRETIC | HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE | 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| UNIRETIC | HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE | 12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 06/27/1997 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 09/13/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020729Orig1s026ltr.pdf | |
| 01/19/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025ltr.pdf | |
| 08/23/2011 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020729s024ltr.pdf | |
| 05/19/2011 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s023lbl.pdf | |
| 01/13/2010 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020729s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020729s021ltr.pdf | |
| 10/29/2003 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr024ltr.pdf |
| 02/14/2002 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20729s10ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020729_S010_UNIRETIC.pdf |
| 09/24/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/2000 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/12/2001 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/21/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/18/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/13/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s026lbl.pdf | |
| 01/19/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020729s025lbl.pdf | |
| 08/23/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s024lbl.pdf | |
| 05/19/2011 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020729s023lbl.pdf | |
| 01/13/2010 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020729s021lbl.pdf |