Application 022522
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DALIRESP | ROFLUMILAST | TABLET;ORAL | 500MCG | Yes | Yes |
| 002 | DALIRESP | ROFLUMILAST | TABLET;ORAL | 250MCG | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0310-0088 | Daliresp | roflumilast | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0088 | Daliresp | roflumilast | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0088 | Daliresp | roflumilast | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0088 | Daliresp | roflumilast | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0095 | Daliresp | roflumilast | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0095 | Daliresp | roflumilast | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0095 | Daliresp | roflumilast | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0095 | Daliresp | roflumilast | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 55154-4625 | Daliresp | roflumilast | Cardinal Health | NDA | Current |