Application 204516
- Type
- NDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BRISDELLE | PAROXETINE MESYLATE | CAPSULE;ORAL | EQ 7.5MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0574-0279 | Paroxetine | paroxetine | Paddock Laboratories, LLC | NDA | Current |
| 0574-0279 | Paroxetine | paroxetine | Padagis US LLC | NDA | Current |
| 54766-907 | BRISDELLE | paroxetine | Sebela Pharmaceuticals Inc. | NDA | Current |
| 54766-907 | BRISDELLE | paroxetine | Sebela Pharmaceuticals Inc. | NDA | Current |
| 54766-907 | BRISDELLE | paroxetine | Sebela Pharmaceuticals Inc. | NDA | Current |