Orange Book product · Brand (NDA)
AVAPRO
IRBESARTAN
At a glance
Sep 30, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 1997
29 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
IRBESARTAN
Strength
75MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020757
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.
- 2025IRBESARTANGeneric (ANDA)
ANDA 219539 · MSN
- 2024IRBESARTANGeneric (ANDA)
ANDA 211056 · IPCA LABS LTD
- 2018IRBESARTANGeneric (ANDA)
ANDA 204740 · AMNEAL PHARMS
- 2016IRBESARTANGeneric (ANDA)
ANDA 206194 · HISUN PHARM HANGZHOU
- 2015IRBESARTANGeneric (ANDA)
ANDA 203685 · AJANTA PHARMA LTD
- 2015IRBESARTANGeneric (ANDA)
ANDA 204774 · SCIEGEN PHARMS
- 2015IRBESARTANGeneric (ANDA)
ANDA 203020 · UNICHEM
- 2015IRBESARTANGeneric (ANDA)
ANDA 203534 · JUBILANT GENERICS
- 2012IRBESARTANGeneric (ANDA)
ANDA 077205 · CHARTWELL MOLECULAR
- 2012IRBESARTANGeneric (ANDA)
ANDA 091236 · ALEMBIC PHARMS LTD
- 2012IRBESARTANGeneric (ANDA)
ANDA 200832 · APOTEX INC
- 2012IRBESARTANGeneric (ANDA)
ANDA 090201 · HIKMA
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.
