Application 208294
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Application Products#
Product, Drug, Ingredient table| 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 table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65170 | SUPPL | 2020-11-09 |
| 65165 | SUPPL | 2020-11-09 |
| 58939 | SUPPL | 2019-06-04 |
| 58895 | SUPPL | 2019-05-30 |
| 52884 | ORIG | 2018-03-09 |
| 32905 | ORIG | 2016-04-27 |
| 19991 | ORIG | 2016-04-27 |