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NDA

DICLOFENAC SODIUM | N020037 | NOVARTIS PHARMACEUTICALS CORP

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 Chain12 active DMFs12 inactive

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

DIPHARMA FRANCIS SRLDICLOFENAC SODIUM EP/USP

DMF 66891986

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC SODIUM

DMF 69811987

CHENG FONG CHEMICAL CO LTDDICLOFENAC SODIUM

DMF 81921989

OLON SPADICLOFENAC SODIUM

DMF 89241991

SYN-TECH CHEM AND PHARM CO LTDDICLOFENAC SODIUM USP

DMF 98991992

UNIQUE CHEMICALSDICLOFENAC SODIUM USP

DMF 124691997

NINGBO SMART PHARMACEUTICAL CO LTDDICLOFENAC SODIUM

DMF 188772005

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DICLOFENAC SODIUM USP

DMF 208492007

HENAN DONGTAI PHARM CO LTDDICLOFENAC SODIUM

DMF 245802011

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC SODIUM (PROCESS II)

DMF 353632020

MACLEODS PHARMACEUTICALS LTDDICLOFENAC SODIUM USP

DMF 381552023

KREATIVE ORGANICS PRIVATE LTDDICLOFENAC SODIUM USP

DMF 424612025

HEUMANN PCS GMBHInactiveDICLOFENAC SODIUM

DMF 81211989

PROSINTEX SPAInactiveDICLOFENAC SODIUM

DMF 85831990

YONEZAWA HAMARI CHEMICALS LTDInactiveDICLOFENAC SODIUM

DMF 86881990

MEDICHEM SAInactiveDICLOFENAC SODIUM

DMF 89161991

ESTEVE QUIMICA SAInactiveDICLOFENAC SODIUM

DMF 91151991

IROTEC LABORATORIESInactiveDICLOFENAC SODIUM

DMF 103601993

ASSIA CHEMICAL INDUSTRIES LTDInactiveDICLOFENAC SODIUM

DMF 114991995

AMOLI ORGANICS LTDInactiveDICLOFENAC SODIUM

DMF 116761995

FARCHEMIA SRLInactiveDICLOFENAC SODIUM

DMF 117001995

EXCELLA GMBHInactiveDICLOFENAC SODIUM

DMF 151812000

ESTEVE QUIMICA SAInactiveDICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE

DMF 232002009

HAINAN POLY PHARMACEUTICAL CO LTDInactiveDICLOFENAC SODIUM EXTENDED RELEASE CAPSULES

DMF 232432009

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Sep 14, 2012	SUPPL -31	View Letter (PDF)
Apr 13, 2011	SUPPL -23	View Letter (PDF)
Sep 6, 2007	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 28, 1991

No patent or exclusivity listings for this strength.