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E.E.S.

NDA

ERYTHROMYCIN ETHYLSUCCINATE | N050297 | 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 Chain6 active DMFs9 inactive

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

ABBVIE INCERYTHROMYCIN ETHYLSUCCINATE

DMF 134431998

ERCROS SAERYTHROMYCIN ETHYLSUCCINATE

DMF 136541998

ALEMBIC PHARMACEUTICALS LTDERYTHROMYCIN ETHYLSUCCINATE USP

DMF 314512017

SM BIOMED SDN BHDERYTHROMYCIN ETHYLSUCCINATE USP

DMF 317542017

CENTURY PHARMACEUTICALS LTDERYTHROMYCIN ETHYLSUCCINATE USP

DMF 345812020

SOLARA ACTIVE PHARMA SCIENCES LTDERYTHROMYCIN ETHYLSUCCINATE USP

DMF 350462020

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 132931998

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135111998

ARCHIFAR LABInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 136001998

POLFAInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135801998

DSM ANDENO GMBHInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135811998

GIST-BROCADES NV PHARMACEUTICALSInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135831998

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135891998

FERMIC SA DE CVInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 137111998

SANDOZ INDUSTRIAL PRODUCTS SPAInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 157892001

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Aug 17, 2012	SUPPL -31	View Letter (PDF)
Nov 8, 2010	SUPPL -29	View Letter (PDF)
Dec 19, 2008	SUPPL -30	View Letter (PDF)
May 28, 2008	SUPPL -28	View Letter (PDF)
Jan 9, 2008	SUPPL -27	View Letter (PDF)
Aug 14, 2006	SUPPL -21	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)

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#002 — EQ 200MG BASE

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — EQ 200MG BASE

0 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Jul 5, 1988