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CEFAZOLIN SODIUM

NDA

CEFAZOLIN SODIUM | N211413 | HQ SPECIALTY PHARMA CORP

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 Chain3 active DMFs11 inactive

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

ACS DOBFAR SPACEFAZOLIN SODIUM LYOPHILIZED (STERILE, BULK)

DMF 132081998

SANDOZ GMBHCEFAZOLIN SODIUM (STERILE)

DMF 141331999

ORCHID PHARMA LTDCEFAZOLIN USP

DMF 150222000

HOECHST AGInactiveCEFAZOLIN SODIUM INJECTION (STERILE FILLING)

DMF 67841987

GEMA SAInactiveCEFAZOLIN

DMF 81371989

BIOCHEMIC GESELLSCHAFT MBHInactiveCEFAZOLIN

DMF 86341990

ASTELLAS PHARMA INCInactiveCEFAZOLIN

DMF 101561991

ACS DOBFAR SPAInactiveCEFAZOLIN SODIUM

DMF 136901998

BRISTOL MYERS SQUIBB COInactiveCEFAZOLIN SODIUM

DMF 137071998

TEVA PHARMACEUTICALS USA INCInactiveCEFAZOLIN SODIUM

DMF 137411998

BRISTOL MYERS SQUIBB COInactiveCEFAZOLIN SODIUM

DMF 137501998

ASTELLAS PHARMA INCInactiveCEFAZOLIN SODIUM (STERILE)

DMF 137971998

AUROBINDO PHARMA LTDInactiveCEFAZOLIN SODIUM USP

DMF 183862005

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFAZOLIN SODIUM (STERILE)

DMF 245272011

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 18, 2026	SUPPL -3	View Letter (PDF)
May 9, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2GM BASE/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: May 8, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 3GM BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Mar 8, 2024