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ZINACEF IN PLASTIC CONTAINER

NDA

CEFUROXIME SODIUM | N050643 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Primus Pharmaceuticals, Inc. FDA-2026-P-8647 · 66 docket documents Primus Pharmaceuticals, Inc. filed a citizen petition requesting that the FDA clarify its regulatory requirements and policy regarding the submission of data and information relating to the CMC sections of an NDA or ANDA for topical ophthalmic products, specifically to address the role of contract m	Other	2026-08-06	Open	Primus Pharmaceuticals, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

42 trials from ClinicalTrials.gov — 2 recruiting, 28 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision NCT07753629	N/A	Not Yet Recruiting	Seoul National University Hospital	58	2026-08-07 → 2028-07-31
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)NCT07492134	Phase 2	Recruiting	Vanderbilt University Medical Center	100	2026-07-07 → 2028-10-01
Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?NCT00492973	N/A	Completed	New Lexington Clinic	101	2006-03 → 2008-02
An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia NCT00648726	Phase 3	Completed	Pfizer	139	2003-01 → 2003-08
Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section NCT01138852	Phase 4	Completed	Attikon Hospital	176	2004-07 → 2008-12
24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis NCT04303390	Phase 4	Completed	Saud Al Babtain Cardiac Center	568	2018-02-06 → 2022-05-31
Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy NCT02169856	N/A	Completed	Benazir Bhutto Hospital, Rawalpindi	50	2013-07 → 2014-02
Antibiotic Prophylaxis in the Prevention of Surgical Site Infections After Selected Urgent Abdominal Surgical Procedures NCT01524081	Phase 3	Completed	The Faculty Hospital Na Bulovce	187	2008-07 → 2011-11
Antibiotic Prophylaxis for Transrectal Prostate Biopsy NCT01659866	Phase 4	Completed	Northwestern University	563	2012-08 → 2016-08
Antibiotic Prophylaxis in Total Knee Prosthesis NCT00497341	Phase 4	Completed	Hospital Clinic of Barcelona	1,332	2008-01 → 2010-08

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain5 active DMFs10 inactive

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

ACS DOBFAR SPACEFUROXIME SODIUM (STERILE BULK)

DMF 132051998

FARMABIOS SPACEFUROXIME SODIUM STERILE USP

DMF 187222005

GLAXOSMITHKLINE LLCCEFUROXIME SODIUM

DMF 244112011

NECTAR LIFESCIENCES LTDCEFUROXIME SODIUM USP (STERILE) DRUG SUBSTANCE

DMF 246272011

STERILE INDIA PVT LTDCEFUROXIME SODIUM USP (STERILE)

DMF 299832016

ELI LILLY AND COInactiveCEFUROXIME SODIUM

DMF 136751998

FARMABIOS SRLInactiveCEFUROXIME SODIUM STERILE

DMF 141371999

FRESENIUS KABI ANTI INFECTIVES SRLInactiveCEFUROXIME SODIUM STERILE

DMF 155502001

FARMABIOS SPAInactiveCEFUROXIME SODIUM (INTERMEDIATE)

DMF 163252002

WOCKHARDT LTDInactiveCEFUROXIME SODIUM (STERILE)

DMF 166492003

AUROBINDO PHARMA LTDInactiveCEFUROXIME SODIUM

DMF 185302005

AUROBINDO PHARMA LTDInactiveCEFUROXIME SODIUM (STERILE) USP

DMF 188852005

QILU ANTIBIOTICS PHARMACEUTICAL CO LTDInactiveCEFUROXIME SODIUM, STERILE BULK ANTIBIOTIC DRUG SUBSTANCE

DMF 195212006

ORCHID CHEMICALS AND PHARMACEUTICALS LTDInactiveCEFUROXIME SODIUM (STERILE)

DMF 203312007

ZHUHAI UNITED LABORATORIES CO LTDInactiveCEFUROXIME SODIUM USP

DMF 261142012

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 18, 2021	SUPPL -27	View Letter (PDF)
Sep 29, 2014	SUPPL -22	View Letter (PDF)
Jul 31, 2007	SUPPL -21	View Letter (PDF)
May 26, 2004	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 15MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 28, 1989

No patent or exclusivity listings for this strength.

#002 — EQ 30MG BASE/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 28, 1989