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CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA

CEFTIZOXIME SODIUM | N050589 | ASTELLAS PHARMA US INC

4 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 Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

PURE AND CURE HEALTHCARE PRIVATE LTDCEFTIZOXIME SODIUM (STERILE) USP

DMF 244542010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 21, 2005	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 20MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 3, 1984

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 3, 1984

#003 — EQ 20MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 13, 1995

#004 — EQ 40MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 13, 1995