Cefprozil

Overview

Cefprozil is a cephalosporin antibiotic that is commonly employed to treat a variety of bacterial infections, including those of the ear and skin, bronchitis, and others.

Indication

For the treatment of the following infections (respiratory, skin, soft tissue, UTI, ENT) caused by; S. pneumoniae, H. influenzae, staphylococci, S. pyogenes (group A beta-hemolytic streptococci), E. coli, P. mirabilis, Klebsiella sp, coagulase-negative staph

Associated Conditions

Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
Bacterial Infections
Community Acquired Pneumonia (CAP)
Streptococcal Pharyngitis
Tonsillitis streptococcal
Urinary Tract Infection
Bacterial otitis media
Uncomplicated skin and subcutaneous tissue bacterial infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP	2024/07/10	NCT06494072	Phase 4	Recruiting	Medical College of Wisconsin
Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers	2020/06/04	NCT04414254	Phase 1	Completed	The Affiliated Hospital of Qingdao University
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions	2009/04/15	NCT00881855	Phase 1	Completed	Sandoz
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.	2009/04/15	NCT00881153	Phase 1	Completed	Sandoz
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions	2009/04/15	NCT00881426	Phase 1	Completed	Sandoz
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions	2009/04/15	NCT00881400	Phase 1	Completed	Sandoz
Cefprozil 500 mg Tablets Under Fasting Conditions	2009/02/10	NCT00840281	Phase 1	Completed	Teva Pharmaceuticals USA
Cefprozil 500 mg Tablets Under Fed Conditions	2009/02/10	NCT00840866	Phase 1	Completed	Teva Pharmaceuticals USA
Cefprozil for Oral Suspension 250 mg/5 mL, Fasting	2009/02/03	NCT00835614	Phase 1	Completed	Teva Pharmaceuticals USA
Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting	2009/02/03	NCT00835354	Phase 1	Completed	Teva Pharmaceuticals USA

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CEFPROZIL	RedPharm Drug Inc.	67296-0590	ORAL	500 mg in 1 1	7/7/2011
Cefprozil	A-S Medication Solutions	50090-1188	ORAL	500 mg in 1 1	8/9/2018
Cefprozil	Rising Health, LLC	57237-034	ORAL	125 mg in 5 mL	10/26/2022
Cefprozil	Physicians Total Care, Inc.	54868-5757	ORAL	250 mg in 5 mL	12/8/2010
Cefprozil	Teva Pharmaceuticals USA, Inc.	0093-1077	ORAL	250 mg in 1 1	8/31/2018
Cefprozil	Aurobindo Pharma Limited	65862-099	ORAL	125 mg in 5 mL	12/31/2021
Cefprozil	Aurobindo Pharma Limited	65862-068	ORAL	250 mg in 1 1	12/23/2021
Cefprozil	Rising Health, LLC	57237-035	ORAL	250 mg in 5 mL	10/26/2022
CEFPROZIL	Wockhardt USA LLC.	64679-713	ORAL	500 mg in 1 1	11/26/2019
Cefprozil	A-S Medication Solutions	50090-1739	ORAL	500 mg in 1 1	9/24/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SANDOZ CEFPROZIL	Sandoz Canada, Inc.	02302187	Tablet - Oral	500 MG	1/24/2008
APO-CEFPROZIL	Apotex Inc	02293951	Powder For Suspension - Oral	250 MG / 5 ML	4/20/2007
NU-CEFPROZIL	nu-pharm inc	02336340	Powder For Suspension - Oral	125 MG / 5 ML	N/A
CEFZIL TABLETS - 250MG	bristol-myers squibb canada	02163659	Tablet - Oral	250 MG	12/31/1995
CEFZIL POWDER FOR ORAL SUSPENSION-125MG/5ML	bristol-myers squibb canada	02163675	Powder For Suspension - Oral	125 MG / 5 ML	12/31/1995
NU-CEFPROZIL	nu-pharm inc	02336111	Tablet - Oral	500 MG	N/A
APO-CEFPROZIL	Apotex Inc	02293943	Powder For Suspension - Oral	125 MG / 5 ML	4/20/2007
CEFZIL POWDER FOR ORAL SUSPENSION-250 MG/ 5 ML	bristol-myers squibb canada	02163683	Powder For Suspension - Oral	250 MG / 5 ML	12/31/1995
NU-CEFPROZIL	nu-pharm inc	02336359	Powder For Suspension - Oral	250 MG / 5 ML	N/A
NU-CEFPROZIL	nu-pharm inc	02336103	Tablet - Oral	250 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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