Application 020312
- Type
- NDA
- Sponsor
- UCB INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | UNIVASC | MOEXIPRIL HYDROCHLORIDE | TABLET;ORAL | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | UNIVASC | MOEXIPRIL HYDROCHLORIDE | TABLET;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0091-3707 | Univasc | moexipril hydrochloride | UCB, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 24764 | SUPPL | 2012-09-18 |
| 12438 | SUPPL | 2012-09-18 |
| 12437 | SUPPL | 2012-01-23 |
| 2324 | SUPPL | 2012-01-23 |
| 12436 | SUPPL | 2011-09-02 |
| 24763 | SUPPL | 2011-08-26 |
| 12435 | SUPPL | 2010-01-29 |
| 24762 | SUPPL | 2010-01-15 |
| 23575 | ORIG | 2006-06-09 |
| 2323 | SUPPL | 2003-11-25 |
| 41278 | ORIG | 2002-09-13 |
| 2322 | SUPPL | 2001-04-11 |
| 57395 | ORIG | 1995-04-19 |