Glycopyrrolate Inhalant Powder
- Brand(s)
- Seebri
- 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
- FDAOB
- INHALATION\POWDER\GLYCOPYRROLATE\rdfq
- SPL Active
- ORAL\CAPSULE\GLYCOPYRROLATE
- SPL Moiety
- ORAL\CAPSULE\GLYCOPYRRONIUM
product(s) by strength(s)
glycopyrrolate 0.0156 mg inhalant powder
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000780662 | Seebri | NDA | Novartis Pharmaceuticals Corporation | 2015-10-29 | GLYCOPYRROLATE | ORAL | CAPSULE | NDA207923 | 8839674f-26d6-4302-9da0-258decfba9aa |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | NDA207923 | SEEBRI | NOVARTIS PHARMACEUTICALS CORP | 2015-10-29 | NDA207923_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA207923_001 | RX | GLYCOPYRROLATE (15.6MCG/INH) | POWDER | True | 2015-10-29 | SEEBRI |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 8839674f-26d6-4302-9da0-258decfba9aa (view SPL) | These highlights do not include all the information needed to use SEEBRI NEOHALER safely and effectively. See full prescribing information for SEEBRI NEOHALER. SEEBRI NEOHALER (glycopyrrolate) inhalation powder, for oral inhalation useInitial U.S. Approval: 1961 | prescription | Human Prescription | Novartis Pharmaceuticals Corporation | 2015-10-29 | 1 | 000780662 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII