Orange Book product · Brand (NDA)
ATROVENT
IPRATROPIUM BROMIDE
At a glance
Oct 20, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 1995
31 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
IPRATROPIUM BROMIDE
Strength
0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
NDA 020393
Product number
001
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.
- 2004ATROVENT HFABrand (NDA)
NDA 021527 · BOEHRINGER INGELHEIM
- 1995ATROVENTBrand (NDA)
NDA 020394 · BOEHRINGER INGELHEIM
- 1993ATROVENTBrand (NDA)
NDA 020228 · BOEHRINGER INGELHEIM
- 1986ATROVENTBrand (NDA)
NDA 019085 · BOEHRINGER INGELHEIM
- 2026IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 217953 · ARMSTRONG PHARMS
- 2025IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 217912 · LUPIN
- 2025IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 217886 · LUPIN
- 2025IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 219222 · RUBICON RESEARCH
- 2024IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 219221 · RUBICON RESEARCH
- 2022IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 215104 · AMNEAL
- 2022IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 215105 · AMNEAL
- 2017IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 207903 · SUN PHARM
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.
