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NDA

ERYTHROMYCIN | N050526 | WESTWOOD SQUIBB PHARMACEUTICALS 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Center for Food Safety and Institute for Agriculture and Trade Policy - Citiz... FDA-2013-P-0351 · 4 docket documents The Center for Food Safety and Institute for Agriculture and Trade Policy filed this citizen petition on March 15, 2013, requesting that the FDA prohibit the use of antibiotics such as penicillin, virginiamycin, erythromycin, tylosin, and tetracycline in the production of distillers grains sold as a	Other	2013-04-11	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

61 trials from ClinicalTrials.gov — 2 recruiting, 36 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Motilin on the Frequency and Amount of Food Intake NCT03024879	Phase 4	By Invitation	Universitaire Ziekenhuizen KU Leuven	15	2014-03 → 2025-03
Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients NCT03883269	Phase 4	Recruiting	Centre for Human Drug Research, Netherlands	30	2018-03-20 → 2019-12
A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804 NCT01589614	Phase 1	Completed	Pfizer	12	2012-06 → 2012-08
Chronic Bronchiolitis or Resistant Asthma?NCT00368342	Phase 4	Completed	Baqiyatallah Medical Sciences University	—	—
Topical Antibiotic Prophylaxis for Eyelids NCT03199911	Phase 4	Completed	University of California, San Francisco	401	2017-10-02 → 2019-11-14
Transplacental Transfer of Drugs Used in Pregnant Women NCT02622802	N/A	Completed	University Hospital, Gasthuisberg	250	2012-11 → 2017-05
An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia NCT00648726	Phase 3	Completed	Pfizer	139	2003-01 → 2003-08
Clinical Trial of Eye Prophylaxis in the Newborn NCT00000120	Phase 3	Completed	National Eye Institute (NEI)	—	1985-01
Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission NCT00021671	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	3,720	— → 2004-11
Intradermal LPS and Antibiotics NCT03779360	N/A	Completed	Centre for Human Drug Research, Netherlands	32	2018-10-12 → 2019-02-23

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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

1 letter from Drugs@FDA

Date	Submission	Document
Dec 15, 2002	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.