Orange Book product · Brand (NDA)
ACIPHEX SPRINKLE
RABEPRAZOLE SODIUM
At a glance
Mar 26, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 26, 2013
13 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
RABEPRAZOLE SODIUM
Strength
10MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 204736
Product number
002
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.
- 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 090678 · LANNETT CO INC
- 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.
