Glycopyrrolate / indacaterol Inhalant Powder
- Brand(s)
- Utibron
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Novartis Pharmaceuticals Corporation (2015-10-29)
- Oldest Current Product
- 2015-10-29
- License(s)
- NDA
- RxNORM
- INHALANT POWDER\GLYCOPYRROLATE:INDACATEROL
- FDAOB
- INHALATION\POWDER\GLYCOPYRROLATE: INDACATEROL MALEATE\rdfq
- SPL Active
- ORAL\CAPSULE\GLYCOPYRROLATE: INDACATEROL MALEATE
- SPL Moiety
- ORAL\CAPSULE\GLYCOPYRRONIUM: INDACATEROL
product(s) by strength(s)
glycopyrrolate 0.0156 mg / indacaterol 0.0275 mg inhalant powder
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000780664 | Utibron | NDA | Novartis Pharmaceuticals Corporation | 2015-10-29 | GLYCOPYRROLATE, INDACATEROL MALEATE | ORAL | CAPSULE | NDA207930 | 7782a48e-38bb-404a-94ef-051278d8bfef |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | NDA207930 | UTIBRON | NOVARTIS PHARMACEUTICALS CORP | 2015-10-29 | NDA207930_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA207930_001 | RX | GLYCOPYRROLATE (15.6MCG/INH), INDACATEROL MALEATE (27.5MCG/INH) | POWDER | True | 2015-10-29 | UTIBRON |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 7782a48e-38bb-404a-94ef-051278d8bfef (view SPL) | These highlights do not include all the information needed to use UTIBRON NEOHALER safely and effectively. See full prescribing information for UTIBRON NEOHALER. UTIBRONTM NEOHALER (indacaterol and glycopyrrolate) inhalation powder, for oral inhalation use Initial U.S. Approval: 2015 | prescription | Human Prescription | Novartis Pharmaceuticals Corporation | 2015-10-29 | 1 | 000780664 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII