Orange Book product · Brand (NDA)
ACIPHEX
RABEPRAZOLE SODIUM
At a glance
May 29, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 29, 2002
24 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
RABEPRAZOLE SODIUM
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 020973
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.
- 2013ACIPHEX SPRINKLEBrand (NDA)
NDA 204736 · AYTU
- 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.
