Application 022004
- Type
- NDA
- Sponsor
- COVIS PHARMA BV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMNARIS | CICLESONIDE | SPRAY, METERED;NASAL | 0.05MG/INH | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63402-701 | Omnaris | ciclesonide | Sunovion Pharmaceuticals | NDA | Current |
| 63402-701 | Omnaris | ciclesonide | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 70515-701 | Omnaris | ciclesonide | Covis Pharma | NDA | Current |
| 70515-701 | Omnaris | ciclesonide | Covis Pharma | NDA | Current |
| 70515-701 | Omnaris | ciclesonide | Covis Pharma US, Inc | NDA | Current |
| 70515-701 | Omnaris | ciclesonide | Covis Pharma | NDA | Current |
| 70515-701 | Omnaris | ciclesonide | Covis Pharma US, Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58699 | SUPPL | 2019-05-14 |
| 58645 | SUPPL | 2019-05-13 |
| 6663 | SUPPL | 2016-03-21 |
| 29049 | SUPPL | 2013-03-26 |
| 16746 | SUPPL | 2013-03-26 |
| 38066 | SUPPL | 2010-05-17 |
| 6662 | SUPPL | 2010-05-12 |
| 6661 | SUPPL | 2010-05-12 |
| 16745 | SUPPL | 2007-11-26 |
| 6660 | SUPPL | 2007-11-26 |
| 21900 | ORIG | 2006-12-22 |
| 6659 | ORIG | 2006-10-26 |
| 38065 | ORIG | 2006-10-23 |