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NDA

IBUPROFEN | N020476 | MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC

1 strength0 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 Chain17 active DMFs33 inactive

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

SI GROUPIBUPROFEN

DMF 53811984

SOLARA ACTIVE PHARMA SCIENCES LTDIBUPROFEN USP

DMF 70531987

BASF CORPIBUPROFEN

DMF 87091990

ADARE PHARMACEUTICALS INCIBUPROFEN GELATIN/CAP

DMF 101651993

SHANDONG XINHUA PHARMACEUTICAL CO LTDIBUPROFEN

DMF 155112001

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDIBUPROFEN USP

DMF 158392002

ZIBO XINHUA PERRIGO PHARMACEUTICAL CO LTDIBUPROFEN USP DRUG SUBSTANCE

DMF 184132005

BASF CORPIBUPROFEN DC 85

DMF 204212007

DIPHARMA FRANCIS SRLIBUPROFEN LYSINE SALT

DMF 214442008

IOL CHEMICALS AND PHARMACEUTICALS LTDIBUPROFEN USP

DMF 224312009

IPC PROCESS CENTER GMBH AND CO KGIBUPROFEN DC100 (IBUPROFEN PH. EUR., GRANULATED)

DMF 232422009

SMS PHARMACEUTICALS LTDIBUPROFEN USP

DMF 352152020

LUNA CHEMICAL INDUSTRIES PVT LTDIBUPROFEN USP

DMF 369352022

SOLARA ACTIVE PHARMA SCIENCES LTDIBUPROFEN ARGININE

DMF 369922022

SHIJIAZHUANG CREADY PHARMACEUTICAL R AND D INCIBUPROFEN GRANULES DC 85%

DMF 388092023

SMS PHARMACEUTICALS LTDIBUPROFEN ARGININE

DMF 418492025

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDIBUPROFEN ARGININE DRUG SUBSTANCE

DMF 418862025

KNOLL PHARMA CHEMICALSInactiveIBUPROFEN

DMF 20781973

ETHYL CORPInactiveIBUPROFEN

DMF 29071977

BLASCHIM SPAInactiveIBUPROFEN

DMF 44401982

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPAInactiveIBUPROFEN USP

DMF 45941982

FOREST LABORATORIES INCInactiveIBUPROFEN 800 MG C.R. TABLETS (IN SYNCHRON VEHICLE)

DMF 46441982

INDUSTRIAS QUIMICAS ESTEVE SAInactiveIBUPROFEN

DMF 51661983

ORION CORPInactiveIBUPROFEN

DMF 52051984

YONEZAWA HAMARI CHEMICALS LTDInactiveIBUPROFEN

DMF 53921984

CIPLA LTDInactiveIBUPROFEN USP AS PROCESSED IN FACTORIES NO.2, NO. 3, NO.4 CITED IN DMF

DMF 54381984

ZAMBON SPAInactiveIBUPROFEN USP XX

DMF 54851984

DM GRAHAM LABORATORIES INCInactiveIBUPROFEN TIMED-RELEASE 600 MG. TALBETS

DMF 60371985

ELAN CORP PLCInactiveIBUPROFEN CAPSULES

DMF 61901986

ELAN CORP PLCInactiveIBUPROFEN 300MG. LA CAPSULES

DMF 62101986

ANTIBIOTICOS SPAInactiveIBUPROFEN

DMF 65311986

HEXAGON LABORATORIES INCInactiveIBUPROFEN USP

DMF 65881986

KV PHARMACEUTICAL COInactiveIBUPROFEN DIHYDROCODEINE F.C. TABLETS

DMF 66021986

DR REDDYS LABORATORIES LTDInactiveIBUPROFEN

DMF 66691986

ETHYL CHEMICALS GROUPSInactiveIBUPROFEN

DMF 69271987

MALLINCKRODT CHEMICAL INCInactiveIBUPROFEN DCI-63

DMF 70751987

RALLIS INDIA LTDInactiveIBUPROFEN U.S.P.

DMF 72961987

CHANDRA PHARMACEUTICALS LTDInactiveIBUPROFEN

DMF 77881988

DM GRAHAM LABORATORIES INCInactiveIBUPROFEN S (+) TABLETS

DMF 87271990

SUMITRA PHARMACEUTICALS AND CHEMICALS LTDInactiveIBUPROFEN

DMF 87551990

ARCH PHARMALABS LTDInactiveIBUPROFEN

DMF 91191991

BDH PHARMACEUTICALS LTDInactiveIBUPROFEN BULK DRUG SUBSTANCES

DMF 92381991

CATALENT PHARMA SOLUTIONS LLCInactiveIBUPROFEN SOFTGELS, 200 MG.

DMF 104991993

UNITED BREWERIES LTDInactiveIBUPROFEN USP

DMF 112021994

SHANDONG XIN HUA PHARMACEUTICAL FACTORYInactiveIBUPROFEN BP 88/USP XXII

DMF 112431994

WANBURY LTDInactiveIBUPROFEN BULK DRUG

DMF 126691997

PIRAMAL ENTERPRISES LTDInactiveIBUPROFEN

DMF 143531999

JUHUA GROUP CORP PHARMACEUTICAL FACTORYInactiveIBUPROFEN

DMF 158592002

WANBURY LTDInactiveIBUPROFEN DC GRADE-65%

DMF 199992006

WANBURY LTDInactiveIBUPROFEN DC GRADE-90%

DMF 200432006

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 4, 2002	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

0 patents0 exclusivities▴

SUSPENSION/DROPS;ORAL | Approved: May 25, 1995

No patent or exclusivity listings for this strength.