Albuterol Dry Powder Inhaler
- Brand(s)
- ProAir
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Teva Respiratory, Llc (2015-04-30)
- Oldest Current Product
- 2015-04-27
- License(s)
- NDA
- RxNORM
- DRY POWDER INHALER\ALBUTEROL
- FDAOB
- INHALATION\POWDER, METERED\ALBUTEROL SULFATE\rdfq
- SPL Active
- RESPIRATORY (INHALATION)\POWDER, METERED\ALBUTEROL SULFATE
- SPL Moiety
- RESPIRATORY (INHALATION)\POWDER, METERED\ALBUTEROL
product(s) by strength(s)
200 actuat albuterol 0.09 mg/actuat dry powder inhaler
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 593100580 | ProAir | NDA | Teva Respiratory, Llc | 2015-04-27 | ALBUTEROL SULFATE | RESPIRATORY (INHALATION) | POWDER, METERED | NDA205636 | 9324e2eb-26fd-4f14-9f10-e5aa467306f4 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA205636 | PROAIR RESPICLICK | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC | 2015-03-31 | p6748947, SUBSTANCE p6871646, SUBSTANCE p6701917, SUBSTANCE p6446627, SUBSTANCE p7540282, SUBSTANCE p6718972, SUBSTANCE p8651103, SUBSTANCE p8006690, SUBSTANCE | NEW PRODUCT [2018-03-12] | NDA205636_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA205636_001 | RX | ALBUTEROL SULFATE (EQ 0.090MG BASE/INH) | POWDER, METERED | True | 2015-03-31 | PROAIR RESPICLICK |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6446627 (view patent) | 2017-12-18 | NDA205636, NDA020911, NDA021457 | Beclomethasone Metered Dose Inhaler Albuterol Metered Dose Inhaler |
| 2 | p6701917 (view patent) | 2021-06-23 | NDA205636 | |
| 3 | p6718972 (view patent) | 2021-06-23 | NDA205636 | |
| 4 | p6748947 (view patent) | 2021-06-23 | NDA205636 | |
| 5 | p6871646 (view patent) | 2021-06-23 | NDA205636 | |
| 6 | p7540282 (view patent) | 2023-05-06 | NDA205636 | |
| 7 | p8006690 (view patent) | 2021-06-23 | NDA205636 | |
| 8 | p8651103 (view patent) | 2028-03-26 | NDA205636 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 9324e2eb-26fd-4f14-9f10-e5aa467306f4 (view SPL) | These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR RESPICLICK (albuterol sulfate) inhalation powder, for oralinhalation useInitial U.S. Approval: 1981 | prescription | Human Prescription | Teva Respiratory, Llc | 2015-04-30 | 2 | 593100580 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII