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Details for Generic Name: ceftibuten dihydrate

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Ceftibuten dihydrate is the generic ingredient in one branded drug marketed by Pernix Therap and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for Generic Name: ceftibuten dihydrate

Drug Master File Entries: 0
Suppliers / Packaging: see list11
Therapeutic Class:Antibacterials

Pharmacology for Ingredient: ceftibuten dihydrate

Clinical Trials for: ceftibuten dihydrate

Short-term Antibiotic Therapy for Pyelonephritis in Childhood
Status: Terminated Condition: Pyelonephritis

Patients Response to Early Switch To Oral:Osteomyelitis Study
Status: Not yet recruiting Condition: Osteomyelitis

Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

Phase 3 Study With Carfilzomib and Dexamethasone Versus Velcade and Dexamethasone for Relapsed Multiple Myeloma Patients
Status: Active, not recruiting Condition: Multiple Myeloma

Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
Status: Completed Condition: Macular Degeneration

Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
Status: Completed Condition: Non Small Cell Lung Cancer

Pregabalin In Partial Seizures Extension Study
Status: Completed Condition: Seizures

Expanded Access Program for Maraviroc At Multiple Centers
Status: Completed Condition: Advanced HIV Infection

A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
Status: Completed Condition: Heart Failure

Controlled Trial of Deep Brain Stimulation in Early Patients With Parkinson's Disease
Status: Active, not recruiting Condition: Parkinson Disease

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pernix Therap
ceftibuten dihydrate
CAPSULE;ORAL050685-002Dec 20, 1995RXYes<disabled><disabled>
Pernix Therap
ceftibuten dihydrate
FOR SUSPENSION;ORAL050686-002Dec 20, 1995RXYes<disabled><disabled>
Pernix Therap
ceftibuten dihydrate
FOR SUSPENSION;ORAL050686-001Dec 20, 1995RXYes<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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