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CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER

NDA

CEFOTETAN DISODIUM | N065430 | 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 Chain1 active DMF1 inactive

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

ACS DOBFAR SPACEFOTETAN DISODIUM (STERILE BULK)

DMF 189772005

ASTELLAS PHARMA INCInactiveCEFOTETAN

DMF 50741983

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 31, 2020	SUPPL -9	View Letter (PDF)
Aug 14, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 1GM BASE/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 9, 2007

No patent or exclusivity listings for this strength.

#002 — EQ 2GM BASE/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 9, 2007