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NDA

OMEPRAZOLE MAGNESIUM | N022056 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain11 active DMFs4 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDOMEPRAZOLE MAGNESIUM

DMF 177062004

APITORIA PHARMA PRIVATE LTDOMEPRAZOLE MAGNESIUM USP (NON STERILE DRUG SUBSTANCE)

DMF 229702009

HETERO DRUGS LTDOMEPRAZOLE MAGNESIUM

DMF 249822011

WAVELENGTH ENTERPRISES LTDOMEPRAZOLE MAGNESIUM

DMF 252272011

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDOMEPRAZOLE MAGNESIUM

DMF 277342013

SUN PHARMACEUTICAL INDUSTRIES LTDOMEPRAZOLE MAGNESIUM USP

DMF 303352016

GRANULES INDIA LTDOMEPRAZOLE MAGNESIUM USP

DMF 318292017

METROCHEM API PRIVATE LTDOMEPRAZOLE MAGNESIUM

DMF 353902020

CHROMO LABORATORIES INDIA PRIVATE LTDOMEPRAZOLE MAGNESIUM USP

DMF 385852024

DR REDDYS LABORATORIES LTDOMEPRAZOLE MAGNESIUM (CRYSTALLINE)

DMF 388822023

EVEREST ORGANICS LTDOMEPRAZOLE MAGNESIUM USP

DMF 398122024

MERCK AND CO INCInactiveOMEPRAZOLE MAGNESIUM

DMF 146491999

MYLAN LABORATORIES LTDInactiveOMEPRAZOLE MAGNESIUM USP

DMF 193672006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveOMEPRAZOLE MAGNESIUM USP

DMF 211002007

LUPIN LTDInactiveOMEPRAZOLE MAGNESIUM

DMF 215212008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

23 letters from Drugs@FDA

Date	Submission	Document
Jul 19, 2023	SUPPL -26	View Letter (PDF)
Mar 7, 2022	SUPPL -25	View Letter (PDF)
Mar 7, 2022	SUPPL -25	View Letter (PDF)
Nov 30, 2020	SUPPL -23	View Letter (PDF)
Aug 24, 2018	SUPPL -21	View Letter (PDF)
Jun 14, 2018	SUPPL -22	View Letter (PDF)
Dec 22, 2016	SUPPL -19	View Letter (PDF)
Oct 26, 2016	SUPPL -20	View Letter (PDF)
Feb 4, 2016	SUPPL -18	View Letter (PDF)
Dec 24, 2014	SUPPL -17	View Letter (PDF)
Apr 14, 2014	SUPPL -14	View Letter (PDF)
Feb 27, 2014	SUPPL -15	View Letter (PDF)
May 16, 2013	SUPPL -13	View Letter (PDF)
Oct 11, 2012	SUPPL -11	View Letter (PDF)
Oct 2, 2012	SUPPL -12	View Letter (PDF)
Jan 24, 2012	SUPPL -10	View Letter (PDF)
Jul 6, 2011	SUPPL -7	View Letter (PDF)
May 25, 2011	SUPPL -9	View Letter (PDF)
Jan 25, 2011	SUPPL -8	View Letter (PDF)
Sep 8, 2010	SUPPL -5	View Letter (PDF)
Mar 8, 2010	SUPPL -3	View Letter (PDF)
Dec 4, 2008	SUPPL -1	View Letter (PDF)
Mar 24, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 2.5MG BASE/PACKET

RLD

0 patents0 exclusivities▴

FOR SUSPENSION, DELAYED RELEASE;ORAL | Approved: Mar 20, 2008

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE/PACKET

RLD

0 patents0 exclusivities▾

FOR SUSPENSION, DELAYED RELEASE;ORAL | Approved: Mar 20, 2008