Orange Book product · Generic (ANDA)
RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM
At a glance
Nov 08, 2013
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 08, 2013
12 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
RABEPRAZOLE SODIUM
Strength
20MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 090678
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RABEPRAZOLE SODIUM
- 2013ACIPHEX SPRINKLEBrand (NDA)
NDA 204736 · AYTU
- 2002ACIPHEXBrand (NDA)
NDA 020973 · WAYLIS THERAP
- 2018RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 208644 · ALKEM LABS LTD
- 2017RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 205761 · AUROBINDO PHARMA USA
- 2015RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 204237 · RUBICON RESEARCH
- 2015RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 204179 · AMNEAL PHARMS
- 2013RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 078964 · CHARTWELL RX
- 2013RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 076824 · DR REDDYS
- 2013RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 076885 · PHARMOBEDIENT
- 2013RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 076822 · TEVA PHARMS USA
- 2013RABEPRAZOLE SODIUMGeneric (ANDA)
ANDA 202376 · TORRENT
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.

