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Application 202049
- Type
- NDA
- Sponsor
- CHIESI USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BRONCHITOL | MANNITOL | POWDER;INHALATION | 400MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10122-212 | Bronchitol | mannitol | Chiesi USA, Inc. | NDA | Current |
| 10122-212 | Bronchitol | mannitol | Chiesi USA, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68714 | ORIG | 2021-09-22 |
| 65131 | ORIG | 2020-11-03 |
| 65088 | ORIG | 2020-10-30 |