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CEFAZOLIN AND DEXTROSE

NDA

CEFAZOLIN SODIUM | N050779 | B BRAUN MEDICAL 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 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

13 letters from Drugs@FDA

Date	Submission	Document
Feb 4, 2025	SUPPL -35	View Letter (PDF)
Aug 27, 2024	SUPPL -34	View Letter (PDF)
Oct 12, 2021	SUPPL -31	View Letter (PDF)
Nov 25, 2020	SUPPL -27	View Letter (PDF)
Oct 13, 2015	SUPPL -25	View Letter (PDF)
Sep 23, 2014	SUPPL -23	View Letter (PDF)
Apr 25, 2012	SUPPL -19	View Letter (PDF)
Jan 18, 2012	SUPPL -18	View Letter (PDF)
Nov 7, 2008	SUPPL -11	View Letter (PDF)
Sep 11, 2007	SUPPL -13	View Letter (PDF)
May 17, 2005	SUPPL -6	View Letter (PDF)
Jul 1, 2004	SUPPL -5	View Letter (PDF)
Aug 4, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 500MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 27, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 27, 2000

#003 — EQ 2GM BASE/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 13, 2012

#004 — EQ 3GM BASE/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 26, 2024