Orange Book product · Generic (ANDA)
ALBUTEROL SULFATE
ALBUTEROL SULFATE
At a glance
Mar 12, 2025
Approved
Generic (ANDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 12, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ALBUTEROL SULFATE
Strength
EQ 0.5% BASE
Dosage form
SOLUTION
Route
INHALATION
TE code
AN
Application
ANDA 218386
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ALBUTEROL SULFATE
- 2018PROAIR DIGIHALERBrand (NDA)
NDA 205636 · TEVA BRANDED PHARM
- 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
- 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.
