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PREVACID

NDA

LANSOPRAZOLE | N021281 | TAKEDA PHARMACEUTICALS NORTH AMERICA INC

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 Chain24 active DMFs15 inactive

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

TAPI NL BVLANSOPRAZOLE

DMF 175512004

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)LANSOPRAZOLE

DMF 177872004

MOEHS IBERICA SLLANSOPRAZOLE

DMF 178192004

MATRIX PHARMACORP PRIVATE LTDLANSOPRAZOLE USP

DMF 195552006

ZYDUS LIFESCIENCES LTDLANSOPRAZOLE USP

DMF 197942006

HETERO DRUGS LTDLANSOPRAZOLE

DMF 208732007

DR REDDYS LABORATORIES LTDLANSOPRAZOLE FORM-1

DMF 214262008

WOCKHARDT LTDLANSOPRAZOLE USP

DMF 216052008

ORCHID PHARMA LTDLANSOPRAZOLE (NON-STERILE BULK API)

DMF 216362008

JUBILANT PHARMOVA LTDLANSOPRAZOLE USP

DMF 219882009

SUN PHARMACEUTICAL INDUSTRIES LTDLANSOPRAZOLE USP

DMF 226632009

NATCO PHARMA LTDLANSOPRAZOLE

DMF 235232010

ULKAR KIMYA SANAYII VE TICARET ASLANSOPRAZOLE USP

DMF 237852010

QUIMICA SINTETICA SALANSOPRAZOLE USP

DMF 244872010

ALKEM LABORATORIES LTDLANSOPRAZOLE USP

DMF 251522011

MACLEODS PHARMACEUTICALS LTDLANSOPRAZOLE

DMF 257942012

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDLANSOPRAZOLE

DMF 258772012

LEE PHARMA LTDLANSOPRAZOLE USP

DMF 267992013

MURLI KRISHNA PHARMA PVT LTDLANSOPRAZOLE PELLETS 8.5 % W/W

DMF 274132013

QUIMICA SINTETICA SALANSOPRAZOLE (PROCESS II)

DMF 294622015

MACLEODS PHARMACEUTICALS LTDLANSOPRAZOLE DELAYED - RELEASE PELLETS

DMF 300212015

CHROMO LABORATORIES INDIA PRIVATE LTDLANSOPRAZOLE USP

DMF 353052021

METROCHEM API PRIVATE LTDLANSOPRAZOLE USP

DMF 354852020

MSN ORGANICS PRIVATE LTDLANSOPRAZOLE USP

DMF 415982025

DR REDDYS LABORATORIES LTDInactiveLANSOPRAZOLE FORM-1

DMF 170142003

ITF CHEMICAL LTDAInactiveLANSOPRAZOLE

DMF 182052005

LUPIN LTDInactiveLANSOPRAZOLE USP

DMF 182512005

FLAMMA SPAInactiveLANSOPRAZOLE

DMF 192292006

ESTEVE QUIMICA SAInactiveLANSOPRAZOLE

DMF 193102006

SYN-TECH CHEM AND PHARM CO LTDInactiveLANSOPRAZOLE USP

DMF 195372006

CIPLA LTDInactiveLANSOPRAZOLE USP

DMF 197252006

AREVIPHARMA GMBHInactiveLansoprazole

DMF 210772007

RANBAXY LABORATORIES LTDInactiveLANSOPRAZOLE USP

DMF 211432007

SMS PHARMACEUTICALS LTDInactiveLANSOPRAZOLE USP

DMF 215522008

KRKA DD NOVO MESTOInactiveLANSOPRAZOLE ACTIVE SUBSTANCE

DMF 223212008

DERIVADOS QUIMICOS SA FINE CHEMICALSInactiveLANSOPRAZOLE

DMF 235782010

APOTEX PHARMACHEM INDIA PVT LTDInactiveLANSOPRAZOLE USP

DMF 254932011

IOL CHEMICALS AND PHARMACEUTICALS LTDInactiveLANSOPRAZOLE

DMF 265862012

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveLANSOPRAZOLE

DMF 283802014

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2009	SUPPL -26	View Letter (PDF)
Oct 29, 2008	SUPPL -24	View Letter (PDF)
Apr 23, 2008	SUPPL -22	View Letter (PDF)
Jul 5, 2007	SUPPL -21	View Letter (PDF)
Apr 13, 2006	SUPPL -17	View Letter (PDF)
Jun 23, 2004	SUPPL -14	View Letter (PDF)
Aug 15, 2003	SUPPL -9	View Letter (PDF)
Dec 3, 2002	SUPPL -4	View Letter (PDF)
Aug 30, 2002	SUPPL -7	View Letter (PDF)
May 3, 2002	SUPPL -2	View Letter (PDF)
May 3, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG/PACKET

0 patents0 exclusivities▴

FOR SUSPENSION, DELAYED RELEASE;ORAL | Approved: May 3, 2001

No patent or exclusivity listings for this strength.

#002 — 30MG/PACKET

0 patents0 exclusivities▾

FOR SUSPENSION, DELAYED RELEASE;ORAL | Approved: May 3, 2001