Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020312
Company: UCB INC
Company: UCB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UNIVASC | MOEXIPRIL HYDROCHLORIDE | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| UNIVASC | MOEXIPRIL HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 04/19/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020312Orig1s000rev.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-312_Moexipril_Univasc.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/14/2012 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312Orig1s035ltr.pdf | |
| 01/19/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020312s034,020729s025ltr.pdf | |
| 08/23/2011 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020312s033ltr.pdf | |
| 01/13/2010 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020312s031ltr.pdf | |
| 10/29/2003 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20312slr012,20312slr024ltr.pdf |
| 12/09/2002 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/02/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2001 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20312S16ltr.pdf |
| 03/28/2001 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/18/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/03/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1996 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/09/1996 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1995 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/18/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1995 | 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 |
|---|---|---|---|---|---|
| 09/14/2012 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf | |
| 01/19/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf | |
| 08/23/2011 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf | |
| 01/13/2010 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf |