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CEFTAZIDIME IN DEXTROSE CONTAINER

NDA

CEFTAZIDIME | N050823 | B BRAUN MEDICAL 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 Chain12 active DMFs5 inactive

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

ACS DOBFAR SPACEFTAZIDIME FOR INJECTION USP (STERILE BULK)

DMF 136831998

SANDOZ GMBHCEFTAZIDIME FOR INJECTION

DMF 160822002

ACS DOBFAR SPACEFTAZIDIME DIHYDROCHLORIDE

DMF 176282004

QILU ANTIBIOTICS PHARMACEUTICAL CO LTDCEFTAZIDIME FOR INJECTION

DMF 204812006

ORCHID PHARMA LTDCEFTAZIDIME (STERILE)

DMF 232942009

ORCHID PHARMA LTDCEFTAZIDIME + SODIUM CARBONATE (STERILE BULK)

DMF 232952009

GLAXOSMITHKLINE LLCCEFTAZIDIME

DMF 243392011

PURE AND CURE HEALTHCARE PRIVATE LTDCEFTAZIDIME FOR INJECTION (USP)

DMF 247872011

NECTAR LIFESCIENCES LTDCEFTAZIDIME FOR INJECTION USP (STERILE BULK)

DMF 264692012

ACS DOBFAR SPACEFTAZIDIME FOR INJECTION (STERILE BULK)

DMF 332072019

FRESENIUS KABI IPSUM SRLCEFTAZIDIME PENTAHYDRATE STERILE BUFFERED / AVIBACTAM SODIUM STERILE (4:1)

DMF 387412023

ORCHID PHARMA LTDCEFTAZIDIME + AVIBACTAM (STERILE)

DMF 394082024

GLAXO WELLCOME INCInactiveCEFTAZIDIME PENTAHYDRATE BULK DRUG SUBSTANCE

DMF 136502000

WOCKHARDT LTDInactiveCEFTAZIDIME FOR INJECTION

DMF 167942003

AUROBINDO PHARMA LTDInactiveCEFTAZIDIME DIHYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE INTERMEDIATE

DMF 196442006

AUROBINDO PHARMA LTDInactiveCEFTAZIDIME FOR INJECTION USP (STERILE BULK)

DMF 199982006

KYONGBO PHARMACEUTICAL CO LTDInactiveCEFTAZIDIME STERILE, BULK

DMF 257102011

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Oct 25, 2021	SUPPL -9	View Letter (PDF)
Jul 30, 2019	SUPPL -7	View Letter (PDF)
May 19, 2015	SUPPL -4	View Letter (PDF)
Jun 27, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1GM BASE

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 13, 2011

No patent or exclusivity listings for this strength.

#002 — EQ 2GM BASE

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 13, 2011