Application 208294
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BEVESPI AEROSPHERE | FORMOTEROL FUMARATE; GLYCOPYRROLATE | AEROSOL, METERED;INHALATION | 0.0048MG/INH;0.0090MG/INH | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0310-4600 | BEVESPI AEROSPHERE | Glycopyrrolate and formoterol fumarate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-4600 | BEVESPI AEROSPHERE | Glycopyrrolate and formoterol fumarate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-4600 | BEVESPI AEROSPHERE | Glycopyrrolate and formoterol fumarate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-4600 | BEVESPI AEROSPHERE | Glycopyrrolate and formoterol fumarate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-4600 | BEVESPI AEROSPHERE | Glycopyrrolate and formoterol fumarate | AstraZeneca Pharmaceuticals LP | NDA | Current |