Orange Book product · Brand (NDA)
PROTONIX IV
PANTOPRAZOLE SODIUM
At a glance
Mar 22, 2001
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 22, 2001
25 yr 7 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Aug 12, 2027
in 1 yr 2 mo
Pharmaceutical detail
Active ingredient
PANTOPRAZOLE SODIUM
Strength
EQ 40MG BASE/VIAL
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
NDA 020988
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 2001PROTONIXBrand (NDA)
NDA 020987 · 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
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
Aug 12, 2027
in 1 yr 2 mo
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.
