e-Drug3D

635

OMEPRAZOLE


INN
OMEPRAZOLE
ESOMEPRAZOLE

cas 73590-58-6
CLASS

METABOLISM
ANTISECRETORY (GASTRIC ACID)
PROTON-PUMP INHIBITORS
ANTI-ULCER AGENTS

ROUTE (list)

ORAL INTRAVENOUS

ATC code

A02BC01
A02BD05
A02BD01
A02BD16
A02BC51

PK parameters

F 35 PERCENT
Tmax 2 HOUR
VD 16 LITER
Cl 33 LITER / HOUR
PPB 95 PERCENT
t1/2 0.75 HOUR

Solubility

VERY SLIGHTLY SOLUBLE IN WATER


Target

TARGET H+/K+ ATPASE

DrugCentral

Potassium-transporting ATPase UNIPROT P20648 ATP4A

Download SDF file 6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1H-benzimidazole

Formula:
C17H19N3O3S

Calculated chemical properties:

MW 345.42
NB_atoms 24
XLogP 2.90
PSA 73.853
NB_HD 1
NB_HA 6
fsp3 0.29
Lipinski(0=no;1=yes) 1

FDA
NDA 019810 (label) INN (OMEPRAZOLE) PRILOSEC (ASTRAZENECA) APPROVAL= AP YEAR= 1989 DISCONTINUED
NDA 021153 (label) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM (ASTRAZENECA) APPROVAL= AP YEAR= 2001
NDA 075268 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (GENPHARM) APPROVAL= TA YEAR= 2002 OBSOLETE
NDA 075347 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2002
NDA 075410 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (LANNETT CO INC) APPROVAL= AP YEAR= 2002
NDA 075791 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (SANDOZ) APPROVAL= AP YEAR= 2002 DISCONTINUED
NDA 021229 (label) INN (OMEPRAZOLE MAGNESIUM) PRILOSEC OTC (ASTRAZENECA) APPROVAL= AP YEAR= 2003
NDA 075757 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (SANDOZ) APPROVAL= AP YEAR= 2003
NDA 075876 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (STRIDES PHARMA) APPROVAL= AP YEAR= 2003 DISCONTINUED
NDA 021636 (label) INN (OMEPRAZOLE ; SODIUM BICARBONATE) ZEGERID (SALIX) APPROVAL= AP YEAR= 2004 DISCONTINUED
NDA 021706 (label) INN (OMEPRAZOLE ; SODIUM BICARBONATE) ZEGERID (SANTARUS) APPROVAL= AP YEAR= 2004 NEWAPPLICATION DISCONTINUED
NDA 021689 (label) INN (ESOMEPRAZOLE SODIUM) NEXIUM IV (ASTRAZENECA) APPROVAL= AP YEAR= 2005 DISCONTINUED
NDA 021849 (label) INN (OMEPRAZOLE ; SODIUM BICARBONATE) ZEGERID (SALIX) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 021850 (label) INN (MAGNESIUM HYDROXIDE ; OMEPRAZOLE ; SODIUM BICARBONATE) ZEGERID (SANTARUS) APPROVAL= AP YEAR= 2006 DISCONTINUED
NDA 021957 (label) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM (ASTRAZENECA) APPROVAL= AP YEAR= 2006
NDA 022032 (label) INN (OMEPRAZOLE) OMEPRAZOLE (DEXCEL PHARMA) APPROVAL= AP YEAR= 2007
NDA 075576 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2007
NDA 075785 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (IMPAX LABS) APPROVAL= AP YEAR= 2007
NDA 076048 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (APOTEX) APPROVAL= AP YEAR= 2007
NDA 022056 (label) INN (OMEPRAZOLE MAGNESIUM) PRILOSEC (COVIS) APPROVAL= AP YEAR= 2008
NDA 022101 (label) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM (ASTRAZENECA) APPROVAL= AP YEAR= 2008
NDA 077830 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (RANBAXY) APPROVAL= TA YEAR= 2008 OBSOLETE
NDA 076515 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (SANDOZ) APPROVAL= AP YEAR= 2009
NDA 078490 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009
NDA 022281 (label) INN (OMEPRAZOLE ; SODIUM BICARBONATE) ZEGERID OTC (RILEY CONSUMER) APPROVAL= AP YEAR= 2009
NDA 022456 (label) INN (MAGNESIUM HYDROXIDE ; OMEPRAZOLE ; SODIUM BICARBONATE) MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE (SANTARUS) APPROVAL= AP YEAR= 2009 DISCONTINUED
NDA 078693 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009 OBSOLETE
NDA 078878 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2009
NDA 078966 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2010 DISCONTINUED
NDA 022511 (label) INN (ESOMEPRAZOLE MAGNESIUM ; NAPROXEN) VIMOVO (HORIZON) APPROVAL= AP YEAR= 2010 DISCONTINUED
NDA 050824 (label) INN (AMOXICILLIN ; CLARITHROMYCIN ; OMEPRAZOLE) OMECLAMOX-PAK (CUMBERLAND) APPROVAL= AP YEAR= 2011 DISCONTINUED
NDA 091352 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2012
NDA 022283 (label) INN (OMEPRAZOLE ; SODIUM BICARBONATE) ZEGERID OTC (RILEY CONSUMER) APPROVAL= AP YEAR= 2013
NDA 079182 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2013
NDA 200882 (pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (SUN PHARM) APPROVAL= AP YEAR= 2013 DISCONTINUED
NDA 202342 (label) INN (ESOMEPRAZOLE STRONTIUM) ESOMEPRAZOLE STRONTIUM (BELCHER) APPROVAL= AP YEAR= 2013 DISCONTINUED
NDA 091672 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2014
NDA 204655 (label) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM 24HR (ASTRAZENECA LP) APPROVAL= AP YEAR= 2014
NDA 204152 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (PERRIGO R AND D) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 078003 (label) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CIPLA) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 078936 (label) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (MYLAN) APPROVAL= AP YEAR= 2015
NDA 202384 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (LUPIN LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 203270 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2015
NDA 078279 (label) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2015
NDA 202784 (label) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 203636 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (TORRENT) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 205379 (label) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (ACCORD HLTHCARE) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 207920 (label) INN (ESOMEPRAZOLE MAGNESIUM) NEXIUM 24HR (ASTRAZENECA LP) APPROVAL= AP YEAR= 2015
NDA 201361 (label) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (PERRIGO R AND D) APPROVAL= AP YEAR= 2016
NDA 201946 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 204228 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016
NDA 205606 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2016
NDA 204068 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (DR REDDYS) APPROVAL= AP YEAR= 2016
NDA 204137 (label) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (CHARTWELL RX) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 204922 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (AUROLIFE PHARMA LLC) APPROVAL= AP YEAR= 2016
NDA 204923 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2016
NDA 205103 (label) INN (ASPIRIN ; OMEPRAZOLE) YOSPRALA (GENUS LIFESCIENCES) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 205545 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2016
NDA 207476 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2016
NDA 204657 (pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (EUGIA PHARMA) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 203481 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (BRECKENRIDGE) APPROVAL= AP YEAR= 2017
NDA 204661 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017
NDA 209400 (label) INN (OMEPRAZOLE) OMEPRAZOLE (DEXCEL) APPROVAL= AP YEAR= 2017
NDA 207193 (label) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (PERRIGO R AND D) APPROVAL= AP YEAR= 2017
NDA 202686 (pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (PHARMOBEDIENT) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 207181 (pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (DEVA HOLDING AS) APPROVAL= AP YEAR= 2017
NDA 209339 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017
NDA 205563 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (LANNETT CO INC) APPROVAL= AP YEAR= 2017
NDA 208333 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ALKEM LABS LTD) APPROVAL= AP YEAR= 2017
NDA 202461 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM ; NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (DR REDDYS LABS LTD) APPROVAL= TA YEAR= 2018
NDA 206877 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018
NDA 203290 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2018
NDA 203345 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (ZYDUS) APPROVAL= AP YEAR= 2018
NDA 207265 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HEC PHARM) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 207673 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2018
NDA 209735 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (SUN PHARM) APPROVAL= AP YEAR= 2018
NDA 205070 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (PHARMOBEDIENT) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 207740 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (DR REDDYS) APPROVAL= AP YEAR= 2018
NDA 207891 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (SUN PHARM) APPROVAL= AP YEAR= 2018
NDA 210593 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (SPIL) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 210070 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (APOTEX) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 206296 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2019
NDA 209202 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (P AND L) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 209495 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GLENMARK SPECLT) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 209647 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 209716 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AMNEAL PHARMS NY) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 204012 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2019
NDA 213004 (label) INN (AMOXICILLIN ; OMEPRAZOLE MAGNESIUM ; RIFABUTIN) TALICIA (REDHILL) APPROVAL= AP YEAR= 2019
NDA 212376 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (PHARMOBEDIENT) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 204206 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM ; NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2020
NDA 206582 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (P AND L) APPROVAL= AP YEAR= 2020
NDA 211732 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020
NDA 212587 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (ANDA REPOSITORY) APPROVAL= AP YEAR= 2020
NDA 203349 (pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (GLAND) APPROVAL= AP YEAR= 2020
NDA 208939 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020 DISCONTINUED
NDA 211571 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2020
NDA 211751 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CIPLA) APPROVAL= AP YEAR= 2020
NDA 211752 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CIPLA) APPROVAL= AP YEAR= 2020
NDA 211977 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020
NDA 212088 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (MYLAN) APPROVAL= AP YEAR= 2020
NDA 212507 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020
NDA 212866 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (SUN PHARM) APPROVAL= AP YEAR= 2020
NDA 212977 (pdf not found) INN (OMEPRAZOLE) OMEPRAZOLE (XIROMED) APPROVAL= AP YEAR= 2020
NDA 212949 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CSPC OUYI) APPROVAL= AP YEAR= 2020
NDA 213158 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CISEN) APPROVAL= AP YEAR= 2020
NDA 213859 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GUANGZHOU NOVAKEN) APPROVAL= AP YEAR= 2020
NDA 214278 (label) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DEXCEL) APPROVAL= AP YEAR= 2020 DISCONTINUED
NDA 090841 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ETHYPHARM) APPROVAL= AP YEAR= 2021
NDA 210559 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (INDCHEMIE HEALTH) APPROVAL= AP YEAR= 2021
NDA 213486 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GRAVITI PHARMS) APPROVAL= AP YEAR= 2021
NDA 204920 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM ; NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (MYLAN) APPROVAL= AP YEAR= 2021
NDA 216096 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (L PERRIGO CO) APPROVAL= AP YEAR= 2022
NDA 215732 (pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (SLATE RUN PHARMA) APPROVAL= AP YEAR= 2022
NDA 216349 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GRAVITI PHARMS) APPROVAL= AP YEAR= 2022
NDA 213593 (label) INN (OMEPRAZOLE ; SODIUM BICARBONATE) KONVOMEP (AZURITY) APPROVAL= AP YEAR= 2022
NDA 204470 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM ; NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (ACTAVIS LABS FL INC) APPROVAL= AP YEAR= 2022 DISCONTINUED
NDA 213699 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM ; NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2022
NDA 209791 (pdf not found) INN (ASPIRIN ; OMEPRAZOLE) ASPIRIN; OMEPRAZOLE (TEVA PHARMS USA INC) APPROVAL= TA YEAR= 2023
NDA 213201 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023 DISCONTINUED
NDA 206055 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ZYDUS PHARMS) APPROVAL= AP YEAR= 2023
NDA 214920 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (PRINSTON INC) APPROVAL= AP YEAR= 2023
NDA 216149 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GUARDIAN DRUG) APPROVAL= AP YEAR= 2023
NDA 214473 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023
NDA 217022 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (ZHEJIANG YONGTAI) APPROVAL= AP YEAR= 2023
NDA 217264 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) 0 (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023
NDA 217427 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GRANULES) APPROVAL= AP YEAR= 2023
NDA 217738 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM ; NAPROXEN) NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2023
NDA 217784 (pdf not found) INN (OMEPRAZOLE ; SODIUM BICARBONATE) OMEPRAZOLE AND SODIUM BICARBONATE (DR REDDYS) APPROVAL= AP YEAR= 2024
NDA 207198 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (DR REDDYS) APPROVAL= AP YEAR= 2024
NDA 218092 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (GLENMARK SPECLT) APPROVAL= AP YEAR= 2024
NDA 208511 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2024 DISCONTINUED
NDA 218829 (pdf not found) INN (OMEPRAZOLE MAGNESIUM) OMEPRAZOLE MAGNESIUM (MARKSANS PHARMA) APPROVAL= AP YEAR= 2025
NDA 212651 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (TORRENT) APPROVAL= AP YEAR= 2025
NDA 212652 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (TORRENT) APPROVAL= AP YEAR= 2025
NDA 214046 (pdf not found) INN (ESOMEPRAZOLE SODIUM) ESOMEPRAZOLE SODIUM (EPIC PHARMA LLC) APPROVAL= AP YEAR= 2025
NDA 217714 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (CIPLA) APPROVAL= AP YEAR= 2025
NDA 218948 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2025
NDA 219213 (pdf not found) INN (ESOMEPRAZOLE MAGNESIUM) ESOMEPRAZOLE MAGNESIUM (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2025

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