Application 022301
- Type
- NDA
- Sponsor
- VALEANT PHARMS INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | APRISO | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 375MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0093-9224 | mesalamine | mesalamine | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-9224 | mesalamine | mesalamine | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-9224 | mesalamine | mesalamine | Teva Pharmaceuticals USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0093-9224 | mesalamine | mesalamine | Teva Pharmaceuticals USA, Inc.- | NDA AUTHORIZED GENERIC | Current |
| 43353-884 | APRISO | mesalamine | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 63629-8827 | mesalamine | mesalamine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8827 | mesalamine | mesalamine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, In | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 65649-103 | APRISO | mesalamine | Salix Pharmaceuticals, Inc. | NDA | Current |
| 68682-113 | mesalamine | mesalamine | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-113 | mesalamine | mesalamine | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-113 | mesalamine | mesalamine | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-113 | mesalamine | mesalamine | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-113 | mesalamine | mesalamine | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-113 | mesalamine | mesalamine | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 70748-214 | mesalamine | mesalamine | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-214 | mesalamine | mesalamine | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-214 | mesalamine | mesalamine | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-214 | mesalamine | mesalamine | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |