Orange Book product · Brand (NDA)
COMBIVENT RESPIMAT
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
At a glance
Oct 07, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 07, 2011
14 yr 11 mo ago
Today
Patent 7396341 expires
Listed drug product patent expiration.
Oct 10, 2026
in 4 mo
Patent 9027967 expires
Listed drug product patent expiration.
Mar 31, 2027
in 10 mo
Patent 7837235 expires
Listed drug product patent expiration.
Mar 13, 2028
in 1 yr 9 mo
Patent 8733341 expires
Listed drug product patent expiration.
Oct 16, 2030
in 4 yr 5 mo
Pharmaceutical detail
Active ingredient
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Strength
EQ 0.1MG BASE/INH;0.02MG/INH
Dosage form
SPRAY, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 021747
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.
- 2001DUONEBBrand (NDA)
NDA 020950 · PHARMOBEDIENT
- 1996COMBIVENTBrand (NDA)
NDA 020291 · BOEHRINGER INGELHEIM
- 2020ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 206532 · LUOXIN AUROVITAS
- 2017ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 207875 · SUN PHARM
- 2012ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 202496 · RITEDOSE CORP
- 2007ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 077117 · APOTEX INC
- 2007ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 077559 · CIPLA
- 2007ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 076749 · NEPHRON
- 2007ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 076724 · TEVA PHARMS
- 2007ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 077063 · WATSON LABS TEVA
- 2006ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEGeneric (ANDA)
ANDA 076867 · AIPING PHARM INC
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7396341 | Oct 10, 2026 | in 4 mo | ProductDelisted |
| 9027967 | Mar 31, 2027 | in 10 mo | ProductDelisted |
| 7837235 | Mar 13, 2028 | in 1 yr 9 mo | ProductDelisted |
| 8733341 | Oct 16, 2030 | in 4 yr 5 mo | ProductDelisted |

