Orange Book product · Generic (ANDA)
IRBESARTAN
IRBESARTAN
At a glance
Oct 03, 2012
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 03, 2012
13 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
IRBESARTAN
Strength
75MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 202254
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IRBESARTAN
- 1997AVAPROBrand (NDA)
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- 2018IRBESARTANGeneric (ANDA)
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- 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
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.
