Orange Book product · Brand (NDA)
PROAIR DIGIHALER
ALBUTEROL SULFATE
At a glance
Dec 21, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 2018
7 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ALBUTEROL SULFATE
Strength
EQ 0.09MG BASE/INH
Dosage form
POWDER, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 205636
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2004PROAIR HFABrand (NDA)
NDA 021457 · TEVA BRANDED PHARM
- 2001ACCUNEBBrand (NDA)
NDA 020949 · PHARMOBEDIENT
- 2001VENTOLIN HFABrand (NDA)
NDA 020983 · GLAXOSMITHKLINE
- 1996PROVENTIL-HFABrand (NDA)
NDA 020503 · KINDEVA
- 1992VENTOLINBrand (NDA)
NDA 019773 · GLAXOSMITHKLINE
- 1988VENTOLIN ROTACAPSBrand (NDA)
NDA 019489 · GLAXOSMITHKLINE
- 1987VENTOLINBrand (NDA)
NDA 019269 · GLAXOSMITHKLINE
- 1987PROVENTILBrand (NDA)
NDA 019243 · SCHERING
- 2026ALBUTEROL SULFATEGeneric (ANDA)
ANDA 219409 · CIPLA
- 2025ALBUTEROL SULFATEGeneric (ANDA)
ANDA 211600 · AMNEAL IRELAND LTD
- 2025ALBUTEROL SULFATEGeneric (ANDA)
ANDA 218386 · RITEDOSE CORP
- 2024ALBUTEROL SULFATEGeneric (ANDA)
ANDA 212447 · ARMSTRONG PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
