Orange Book product · Brand (NDA)
VENTOLIN HFA
ALBUTEROL SULFATE
At a glance
Apr 19, 2001
Approved
Brand (NDA)
Application
AB3
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 19, 2001
25 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ALBUTEROL SULFATE
Strength
EQ 0.09MG BASE/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
AB3
Application
NDA 020983
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2018PROAIR DIGIHALERBrand (NDA)
NDA 205636 · TEVA BRANDED PHARM
- 2004PROAIR HFABrand (NDA)
NDA 021457 · TEVA BRANDED PHARM
- 2001ACCUNEBBrand (NDA)
NDA 020949 · PHARMOBEDIENT
- 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.
