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NDA

CHLORHEXIDINE GLUCONATE | N019822 | KW GRIFFEN CO

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 Chain9 active DMFs16 inactive

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

XTTRIUM LABORATORIES INCCHLORHEXIDINE GLUCONATE 20% SOLUTION USP

DMF 57821985

FAR SPECIALTY PRODUCTS INC DBA FAR CHEMICALCHLORHEXIDINE GLUCONATE 20% SOLUTION, USP

DMF 191282006

CADILA PHARMACEUTICALS LTDCHLORHEXIDINE GLUCONATE SOLUTION USP

DMF 195832006

RN LABORATORIES PVT LTDCHLORHEXIDINE GLUCONATE 20% SOLUTION

DMF 219462008

MEDICHEM SACHLORHEXIDINE GLUCONATE SOLUTION (DGLP)

DMF 251492011

GARONIT PHARMACEUTICALS INCCHLORHEXIDINE GLUCONATE SOLUTION USP 20%

DMF 254172011

AVA INCCHLORHEXIDINE GLUCONATE 20% SOLUTION, USP

DMF 262132012

SMAART PHARMACEUTTICALSCHLORHEXIDINE GLUCONATE SOLUTION BP

DMF 353332021

HUNAN LIJIE BIOCHEMICAL CO LTDCHLORHEXIDINE GLUCONATE

DMF 373942022

SSL INTERNATIONALInactiveCHLORHEXIDINE GLUCONATE 20% SOLUTION

DMF 17101971

ZENECA PHARMACEUTICALSInactiveCHLORHEXIDINE GLUCONATE 20% SOLUTION B.P.

DMF 30031977

ORION CORP LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION BP 20%

DMF 32901978

WHITMOYER LABS INCInactiveCHLORHEXIDINE (BASE, DIHYDROCHLORIDE, GLUCONATE AND DIACETATE)

DMF 54531984

DELTA SYNTHETIC CO LTDInactiveCHLORHEXIDINE GLUCONATE (BULK)

DMF 59301985

ALCOLAC INCInactiveCHLORHEXIDINE GLUCONATE

DMF 69871987

PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRYInactiveCHLORHEXIDINE GLUCONATE SOLUTION

DMF 83631989

DEGUSSA AG WERK RADEBEULInactiveCHLORHEXIDINE

DMF 84511990

MEDICHEM SAInactiveCHLORHEXIDINE GLUCONATE

DMF 97011992

ARZNEIMITTELWERK DRESDEN GMBHInactiveCHLORHEXIDINE (BASE)

DMF 114651995

ROHIT PLASTICS AND CHEMICALSInactiveCHLORHEXIDINE GLUCONATE 20%

DMF 162062002

BASIC PHARMA CHEMInactiveCHLORHEXIDINE GLUCONATE (BP)

DMF 173012004

GLIDE CHEM PVT LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION 20%

DMF 175592004

BASIC PHARMA LIFE SCIENCE PVT LTDInactiveCHLORHEXIDINE GLUCONATE

DMF 218782008

VIPOR CHEMICALS PRIVATE LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION BP

DMF 230192009

DISHMAN CARBOGEN AMCIS LTDInactiveCHLORHEXIDINE GLUCONATE SOLUTION

DMF 332382018

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 15, 2018	SUPPL -8	View Letter (PDF)
Jan 10, 2013	SUPPL -7	View Letter (PDF)
Jan 9, 2003	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4%

0 patents0 exclusivities▴

SPONGE;TOPICAL | Approved: Mar 31, 1989

No patent or exclusivity listings for this strength.