Orange Book product · Brand (NDA)
PROTONIX
PANTOPRAZOLE SODIUM
At a glance
Jun 12, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 2001
25 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
PANTOPRAZOLE SODIUM
Strength
EQ 20MG BASE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 020987
Product number
002
Marketing status
RX
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.
- 2024PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 217512 · BAXTER HLTHCARE CORP
- 2017PANTOPRAZOLE SODIUMBrand (NDA)
NDA 209463 · HIKMA
- 2007PROTONIXBrand (NDA)
NDA 022020 · WYETH PHARMS
- 2001PROTONIX IVBrand (NDA)
NDA 020988 · WYETH PHARMS
- 2026PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 219973 · SHUANGCHENG
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 215074 · DEVA HOLDING AS
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 217923 · AUROBINDO PHARMA LTD
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 217458 · CIPLA
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 219230 · ALEMBIC
- 2025PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 219087 · GRAVITI PHARMS
- 2024PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 216021 · FRESENIUS KABI USA
- 2024PANTOPRAZOLE SODIUMGeneric (ANDA)
ANDA 215880 · MANKIND PHARMA
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.
