Viewing data from:

ZMAX

NDA

AZITHROMYCIN | N050797 | PF PRISM CV

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 Chain22 active DMFs13 inactive

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

TAPI NL BVAZITHROMYCIN MONOHYDRATE

DMF 152612001

TAPI NL BVAZITHROMYCIN DIHYDRATE

DMF 159722002

TAPI NL BVAZITHROMYCIN N

DMF 159852002

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE USP

DMF 187192005

JUBILANT BIOSYS LTDAZITHROMYCIN MONOHYDRATE USP

DMF 188682005

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP

DMF 207542007

CSPC OUYI PHARMACEUTICAL CO LTDAZITHROMYCIN

DMF 223312008

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE USP (PROCESS-II)

DMF 247542011

LUPIN MANUFACTURING SOLUTIONS LTDAZITHROMYCIN MONOHYDRATE USP (PROCESS B)

DMF 258202012

CALYX CHEMICALS AND PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE

DMF 277132013

MAHIMA LIFE SCIENCES PRIVATE LTDAZITHROMYCIN USP (DIHYDRATE)

DMF 278852013

TARO PHARMACEUTICAL INDUSTRIES LTDAZITHROMYCIN MONOHYDRATE USP

DMF 282942015

HEC PHARM CO LTDAZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM

DMF 288372014

STERILE INDIA PVT LTDAZITHROMYCIN (LYOPHILIZED BULK STERILE)

DMF 299862016

JIANGSU WEIQIDA PHARMACEUTICAL CO LTDAZITHROMYCIN DIHYDRATE

DMF 308872016

JUBILANT BIOSYS LTDAZITHROMYCIN DIHYDRATE USP

DMF 309662016

LUPIN MANUFACTURING SOLUTIONS LTDAZITHROMYCIN DIHYDRATE USP

DMF 334842019

CENTURY PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP

DMF 345832020

KOPRAN RESEARCH LABORATORIES LTDAZITHROMYCIN DIHYDRATE USP

DMF 348532020

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP (ADF PROCESS)

DMF 350342020

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDAZITHROMYCIN DIHYDRATE

DMF 368952022

CALYX CHEMICALS AND PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE

DMF 374102022

WOCKHARDT LTDInactiveAZITHROMYCIN USP

DMF 144801999

SANDOZ INDUSTRIAL PRODUCTS SAInactiveAZITHROMYCIN MONOHYDRATE (NON-STERILE BULK)

DMF 163902003

ITF CHEMICAL LTDAInactiveAZITHROMYCIN MONOHYDRATE

DMF 170102005

ALEMBIC LTD API DIVInactiveAZITHROMYCIN MONOHYDRATE

DMF 170912003

QUIMICA SINTETICA SAInactiveAZITHROMYCIN HYDROGENCITRATE

DMF 179512004

LUPIN LTDInactiveAZITHROMYCIN MONOHYDRATE USP

DMF 193262006

SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTDInactiveAZITHROMYCIN USP (API)

DMF 200742006

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDInactiveAZITHROMYCIN MONOHYDRATE

DMF 202582007

HEC PHARM CO LTDInactiveAZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 208522007

HAINAN POLY PHARMACEUTICAL CO LTDInactiveAZITHROMYCIN GRANULES FOR ORAL SUSPENSION

DMF 234862010

PJ HEALTHCAREInactiveAZITHROMYCIN TASTE MASKING GRANULES 7.5%

DMF 270672013

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveAZITHROMYCIN MONOHYDRATE

DMF 272952013

RUYUAN HEC PHARM CO LTDInactiveAZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE

DMF 284532014

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Nov 23, 2021	SUPPL -26	View Letter (PDF)
Apr 24, 2019	SUPPL -25	View Letter (PDF)
Apr 3, 2017	SUPPL -24	View Letter (PDF)
Feb 13, 2017	SUPPL -21	View Letter (PDF)
May 26, 2016	SUPPL -20	View Letter (PDF)
Jul 10, 2015	SUPPL -19	View Letter (PDF)
Oct 15, 2013	SUPPL -13	View Letter (PDF)
Feb 21, 2013	SUPPL -17	View Letter (PDF)
Mar 5, 2012	SUPPL -16	View Letter (PDF)
Jun 10, 2011	SUPPL -10	View Letter (PDF)
Jun 10, 2011	SUPPL -14	View Letter (PDF)
Jun 10, 2011	SUPPL -12	View Letter (PDF)
Oct 9, 2008	SUPPL -8	View Letter (PDF)
Nov 8, 2007	SUPPL -1	View Letter (PDF)
Jun 14, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2GM BASE/BOT

RLD

0 patents0 exclusivities▴

FOR SUSPENSION, EXTENDED RELEASE;ORAL | Approved: Jun 10, 2005

No patent or exclusivity listings for this strength.