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NDA

ERYTHROMYCIN | N050611 | AZURITY PHARMACEUTICALS 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 Chain15 active DMFs27 inactive

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

ABBVIE INCERYTHROMYCIN BASE

DMF 131971998

POLFA TARCHOMINERYTHROMYCIN

DMF 134091998

ERCROS SAERYTHROMYCIN BASE

DMF 134661998

XIAN LIJUN PHARMACEUTICAL CO LTDERYTHROMYCIN BASE USP 23

DMF 146301999

HEC PHARM CO LTDERYTHROMYCIN THIOCYANATE, PHARMACEUTICAL INTERMEDIATE BULK FORM

DMF 194432006

HEC PHARM CO LTDERYTHROMYCIN USP, NON-STERILE BULK FORM

DMF 194442006

CALYX CHEMICALS AND PHARMACEUTICALS LTDERYTHROMYCIN

DMF 201372006

NINGXIA QIYUAN PHARMACEUTICAL CO LTDERYTHROMYCIN THIOCYANATE

DMF 223322008

NINGXIA QIYUAN PHARMACEUTICAL CO LTDERYTHROMYCIN

DMF 223902008

ALEMBIC PHARMACEUTICALS LTDERYTHROMYCIN USP

DMF 226952009

SM BIOMED SDN BHDERYTHROMYCIN BASE USP

DMF 249562011

UNIMAX CHEMICALS PVT LTDERYTHROMYCIN (HIGH PURITY)

DMF 270312013

ABBVIE INCERYTHROMYCIN BASE

DMF 271552015

SM BIOMED SDN BHDERYTHROMYCIN BASE DIHYDRATE USP

DMF 321212017

ERCROS SAERYTHROMYCIN BASE DIHYDRATE

DMF 373972022

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveERYTHROMYCIN B

DMF 14581969

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveERYTHROMYCIN PHOSPHATE

DMF 29041977

FOREST LABORATORIES INCInactiveERYTHROMYCIN 500MG. C.R.TABLETS

DMF 58581985

ANGUS BIOTECH INCInactiveERYTHROMYCIN

DMF 75671988

PHARMACIA AND UPJOHNInactiveERYTHROMYCIN ENTERIC-COATED TABLETS

DMF 100871991

METABOLIC SOLUTIONS INCInactiveERYTHROMYCIN BREATH TEST DOSE

DMF 121821996

DIASPA TRADE MARK STRIDES ITALIA SRLInactiveERYTHROMYCIN

DMF 133141998

PHARMACIA AND UPJOHNInactiveERYTHROMYCIN

DMF 133361998

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveERYTHROMYCIN

DMF 134061998

GEORGE UHE COInactiveERYTHROMYCIN

DMF 134361998

DSM CAPUA SPAInactiveERYTHROMYCIN

DMF 134461998

FERMIC SA DE CVInactiveERYTHROMYCIN

DMF 134571998

SANDOZ INDUSTRIAL PRODUCTS SPAInactiveERYTHROMYCIN

DMF 134771998

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveERYTHROMYCIN

DMF 135091998

ELI LILLY AND COInactiveERYTHROMYCIN

DMF 135151998

PFIZER INCInactiveERYTHROMYCIN

DMF 135311998

NANTONG PHARMACEUTICAL FACTORYInactiveERYTHROMYCIN

DMF 136351998

CIBRANInactiveERYTHROMYCIN

DMF 136651998

ANGUS BIOTECH INCInactiveERYTHROMYCIN

DMF 137211998

ABBVIE INCInactiveERYTHROMYCIN BASE

DMF 142001998

POLFA TARCHOMIN SAInactiveERYTHROMYCIN THIOCYANATE

DMF 163042002

SANDOZ INDUSTRIAL PRODUCTS SAInactiveERYTHROMYCIN A (E)-9-OXIME

DMF 189092005

XIAN LIJUN PHARMACEUTICAL CO LTDInactiveERYTHROMYCIN THIOCYANATE

DMF 191262006

ANUH PHARMA LTDInactiveERYTHROMYCIN USP

DMF 196762006

NINGXIA QIYUAN PHARMACEUTICAL CO LTDInactiveERYTHROMYCIN THIOCYANATE

DMF 206442007

ANUH PHARMA LTDInactiveErythromycin Oxime

DMF 211292007

YILI CHUANNING BIOTECHNOLOGY CO LTDInactiveERYTHROMYCIN THIOCYANATE PHARMACEUTICAL INTERMEDIATE

DMF 321892017

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Apr 24, 2018	SUPPL -36	View Letter (PDF)
Feb 6, 2012	SUPPL -35	View Letter (PDF)
Feb 7, 2011	SUPPL -27	View Letter (PDF)
Nov 8, 2010	SUPPL -31	View Letter (PDF)
Dec 19, 2008	SUPPL -32	View Letter (PDF)
May 28, 2008	SUPPL -30	View Letter (PDF)
Jan 9, 2008	SUPPL -29	View Letter (PDF)
Aug 14, 2006	SUPPL -22	View Letter (PDF)
Mar 16, 2004	SUPPL -24	View Letter (PDF)
Apr 25, 2002	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 333MG

RLD

0 patents0 exclusivities▴

TABLET, COATED PARTICLES;ORAL | Approved: Sep 9, 1986

No patent or exclusivity listings for this strength.

#002 — 500MG

RLD

0 patents0 exclusivities▾

TABLET, COATED PARTICLES;ORAL | Approved: Aug 22, 1990