Application 022383
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARCAPTA NEOHALER | INDACATEROL MALEATE | POWDER;INHALATION | EQ 75MCG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63402-675 | ARCAPTA NEOHALER | INDACATEROL MALEATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-675 | ARCAPTA NEOHALER | INDACATEROL MALEATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-675 | ARCAPTA NEOHALER | INDACATEROL MALEATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68269 | SUPPL | 2021-08-03 |
| 68268 | SUPPL | 2021-08-03 |
| 68236 | SUPPL | 2021-08-02 |
| 68235 | SUPPL | 2021-08-02 |
| 58956 | SUPPL | 2019-06-04 |
| 58888 | SUPPL | 2019-05-30 |
| 29666 | SUPPL | 2012-12-26 |
| 7309 | SUPPL | 2012-12-26 |
| 7308 | SUPPL | 2012-09-27 |
| 38641 | SUPPL | 2012-09-26 |
| 42503 | ORIG | 2011-08-12 |
| 24294 | ORIG | 2011-08-12 |
| 7307 | ORIG | 2011-07-07 |
| 38640 | ORIG | 2011-07-05 |
| 23391 | ORIG | 2011-07-05 |