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AZACTAM IN PLASTIC CONTAINER

NDA

AZTREONAM | N050632 | BRISTOL MYERS SQUIBB CO

3 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 Chain10 active DMFs3 inactive

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

CURIA ITALY SRLAZTREONAM HYDRATED NON-STERILE ALPHA-FORM

DMF 171842004

TAPI NL BVAZTREONAM USP

DMF 193422006

CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTDAZTREONAM

DMF 268562013

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDAZTREONAM USP

DMF 275082013

CURIA ITALY SRLAZTREONAM BETA FORM

DMF 337312019

CURIA ITALY SRLAZTREONAM ALFA FORM

DMF 337622019

CURIA FRANCE SASAZTREONAM BETA FORM

DMF 380552023

APITORIA PHARMA PRIVATE LTDAZTREONAM USP

DMF 386492023

CURIA FRANCE SASAZTREONAM ALFA FORM

DMF 397312024

FRESENIUS KABI IPSUM SRLAZTREONAM NON STERILE ALPHA

DMF 408412025

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveAZTREONAM

DMF 167512003

ORCHID CHEMICALS AND PHARMACEUTICALS LTDInactiveAZTREONAM

DMF 200142006

CHONGQING FUAN PHARMACEUTICAL CO LTDInactiveAZTREONAM USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 239712010

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jun 21, 2018	SUPPL -19	View Letter (PDF)
Jun 18, 2013	SUPPL -15	View Letter (PDF)
Jan 24, 2008	SUPPL -13	View Letter (PDF)
Dec 30, 2004	SUPPL -12	View Letter (PDF)
Mar 25, 2002	SUPPL -11	View Letter (PDF)
Dec 24, 1998	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 40MG/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 24, 1989

No patent or exclusivity listings for this strength.

#002 — 20MG/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 24, 1989

#003 — 10MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 24, 1989