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Details for Generic Name: erythromycin stearate

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Erythromycin stearate is the generic ingredient in eight branded drugs marketed by Bristol, Parke Davis, Warner Chilcott, Arbor Pharms Llc, Ani Pharms Inc, Lederle, Mylan, Purepac Pharm, Watson Labs, Bristol Myers Squibb, Pfizer, and Wyeth Ayerst, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ninety-five drug master file entries for erythromycin stearate.

Summary for Generic Name: erythromycin stearate

Drug Master File Entries: see list95
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Clinical Trials for: erythromycin stearate

Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes
Status: Withdrawn Condition: Preterm Premature Ruptured Membranes

Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutations in Familial Adenomatous Polyposis
Status: Recruiting Condition: FAP-Familial Adenomatous Polyposis

Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-minors' Adjusted Version
Status: Not yet recruiting Condition: FAP-Familial Adenomatous Polyposis

Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis
Status: Terminated Condition: Gastroparesis

Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin
Status: Recruiting Condition: Epidermolysis Bullosa

TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)
Status: Completed Condition: Hepatitis C Virus

A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function
Status: Completed Condition: Healthy; Renal Insufficiency

Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding
Status: Recruiting Condition: Gastrointestinal Hemorrhage; Hematemesis

Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial
Status: Completed Condition: Variceal Bleeding

Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis
Status: Completed Condition: Blepharitis

The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers
Status: Completed Condition: Healthy

Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
Status: Completed Condition: Bulimia Nervosa; Eating Disorders

Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients
Status: Terminated Condition: Gastroparesis

Neuroprotection With Erythromycin in Cardiac Surgery
Status: Completed Condition: Functional Disturbances Following Cardiac Surgery

An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
Status: Completed Condition: Healthy

Study of Erythromycin in GER-Associated Apnea of the Newborn
Status: Recruiting Condition: Gastroesophageal Reflux; Apnea; Bradycardia

A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804
Status: Completed Condition: Healthy

Erythromycin in Parkinson's Disease
Status: Recruiting Condition: Parkinson's Disease; Levodopa

Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer
Status: Active, not recruiting Condition: Ras-wildtype Colorectal Cancer

PPROM Erythromycin Versus Azithromycin
Status: Completed Condition: Preterm Premature Rupture of Membranes

Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel Motility
Status: Completed Condition: Healthy

Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis
Status: Completed Condition: Subtotal Gastrectomy; Stomach Cancer

Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube
Status: Completed Condition: Pancreatitis

Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy
Status: Not yet recruiting Condition: B-Cell Chronic Lymphocytic Leukemia

The Effect of Intravenous Erythromycin on Gastric Emptying in Non-fasted Patients Before Emergency Total Anesthesia
Status: Completed Condition: Aspiration of Gastric Contents; Gastric Emptying

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
Status: Completed Condition: Pneumonia

Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy
Status: Active, not recruiting Condition: Hepatic Encephalopathy; Hypertension, Portal; Liver Cirrhosis

Use of Erythromycin in Mustard-Induced Bronchiolitis
Status: Completed Condition: Bronchiolitis Obliterans; Acute Obliterating Bronchiolitis

Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects
Status: Not yet recruiting Condition: Healthy Volunteers

Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome
Status: Terminated Condition: Hermansky-Pudlak Syndrome (HPS); Pulmonary Fibrosis; Oculocutaneous Albinism; Platelet Storage Pool Deficiency; Metabolic Disease

Antibiotics Study in Preterm Premature Rupture of the Membranes
Status: Completed Condition: Preterm Premature Rupture of the Membranes

Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.
Status: Recruiting Condition: Upper Gastrointestinal Bleeding

Treatment of Antenatal Chlamydia Infection
Status: Completed Condition: Chlamydia Trachomatis Infection in Pregnancy

The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
Status: Not yet recruiting Condition: Esophagectomy; Postoperative Complications

Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
Status: Terminated Condition: Crohn's Disease

To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil
Status: Completed Condition: Erectile Dysfunction

Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Status: Completed Condition: Infection After Primary Total Knee Arthroplasty

Use of Prokinetics in Early Enteral Feeding in Preterm Infants
Status: Terminated Condition: Feeding Disorder; Nutrition Disorder; Infant,Premature

Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD
Status: Active, not recruiting Condition: COPD

Selections of Subjects With Important Changes in Their Cardiac Repolarization Parameters for the Procurement of Skin and Blood Samples
Status: Completed Condition: Cardiology: RR / QT

Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
Status: Active, not recruiting Condition: Delirium; QT-prolongation

Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma
Status: Not yet recruiting Condition: Pancreatic Adenocarcinoma Metastatic

Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam
Status: Terminated Condition: Length of Pregnancy Prolongation in Hours

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

Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Status: Completed Condition: Colon Ischemia; Aortic Aneurysm

Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer
Status: Completed Condition: Metastatic Breast Cancer

Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Teleangiectasia Patients
Status: Completed Condition: Nervous System Disorder; Genetic Syndrome

A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
Status: Completed Condition: Non-Small Cell Lung Cancer

Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia
Status: Recruiting Condition: Pneumonia

HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy
Status: Completed Condition: Upper Gastrointestinal Bleeding

Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
Status: Completed Condition: HIV Infections

The Inhibition of Platelet Antiaggregating Activity of Clopidogrel by Atorvastatin Detected by Erythromycin Breath Test: a Metabolic Inhibition of Hepatic Cytochrome P450-3A
Status: Recruiting Condition: Hypercholesterolemia; Thrombosis

Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial
Status: Completed Condition: Cholera

Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach
Status: Completed Condition: Emergency Surgery; Full Stomach

Clinical Trial of Eye Prophylaxis in the Newborn
Status: Completed Condition: Chlamydia Infections; Ophthalmia Neonatorum

Pharmacokinetics of Tipranavir Soft Elastic Capsules (SEDDS) and Ritonavir and Their Effects on Cytochrome P-450 (3A4) in Healthy Volunteers
Status: Completed Condition: Healthy

UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer
Status: Completed Condition: HER-2 Positive Metastatic Breast Cancer

Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery
Status: Completed Condition: Post-operative Nausea; Post-operative Vomiting; Nausea Persistent

Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds
Status: Recruiting Condition: Local Pain; Chronic Wounds

An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
Status: Completed Condition: HIV Infections

Chronic Bronchiolitis or Resistant Asthma?
Status: Completed Condition: Asthma

GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia
Status: Active, not recruiting Condition: Acute Lymphoblastic Leukemia, in Relapse

An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
Status: Completed Condition: Visceral Leishmaniasis

Ranolazine and Microvascular Angina by PET in the Emergency Department
Status: Recruiting Condition: Microvascular Angina

The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction
Status: Enrolling by invitation Condition: Heart Failure With Preserved Ejection Fraction

Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer
Status: Withdrawn Condition: Metastatic Pancreatic Adenocarcinoma

Aizthromycin or Clarithromycin in H-pylori Eradication Regimen
Status: Completed Condition: Peptic Ulcer; Dyspepsia; H-pylori

Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy
Status: Completed Condition: Hyperlipidemia; Atherosclerosis

A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting
Status: Completed Condition: Pneumonia

Cognitive Function and Emotional Possessing in Bilateral Facial Palsy
Status: Completed Condition: Intelligence; Emotion

Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
Status: Completed Condition: Acne

Safety Tolerability and Pharmacokinetic of BI 409306
Status: Completed Condition: Healthy

Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department
Status: Recruiting Condition: Abscess

Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
Status: Recruiting Condition: Ischemia

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole
Status: Completed Condition: Healthy

A Pharmacokinetic Study of Oral Cyclophosphamide and Topotecan in Children With Recurrent Solid Tumors
Status: Completed Condition: Solid Tumors

Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Status: Recruiting Condition: Prostate Cancer

Pharmacokinetics of Atorvastatin With Tipranavir/Ritonavir and the Effect of Antacid on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir in Healthy Volunteers
Status: Completed Condition: Healthy

Stem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignances
Status: Completed Condition: Immunosuppression; Leukemia

Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma
Status: Recruiting Condition: Myeloma, Plasma-Cell; Myeloma-Multiple

PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis
Status: Completed Condition: Chronic Bronchitis

Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer
Status: Completed Condition: Breast Cancer; Lung Cancer; Prostate Cancer

Ciprofloxacin Multiple Dose for Adult Cholera
Status: Completed Condition: Cholera

Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization
Status: Withdrawn Condition: Methicillin-resistant Staphylococcus Aureus

Sublingual L-GSH Supplementation in Male Subjects With Smoking Habit and/or Hypertension
Status: Completed Condition: Health Subjects With Cardiovascular Risk Factors

Zinc Supplementation in Cholera Patients
Status: Completed Condition: Cholera

Single Dose Azithromycin in the Treatment of Adult Cholera
Status: Completed Condition: Cholera

Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers
Status: Completed Condition: Kidney Disease

Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections
Status: Completed Condition: Community-acquired Pneumonia

Recovery and Survival of EryDex in Non-patient Volunteers
Status: Recruiting Condition: Healthy

A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries
Status: Not yet recruiting Condition: Contact Lens and Punctal Plug in Preventing Corneal Injuries

The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin
Status: Completed Condition: Gastrointestinal Bleeding

International Ataxia Rating Scale in Younger Patients
Status: Completed Condition: Ataxia Telangiectasia

Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants
Status: Terminated Condition: Enterocolitis, Necrotizing

Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays
Status: Not yet recruiting Condition: Nasal Obstruction; Sneezing; Itching

Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease
Status: Completed Condition: Cardiac Toxicity; Lymphoma

Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients
Status: Completed Condition: Critically Ill

Study of 6-Thioguanine in Combination With 6-Mercaptopurine During Maintenance Therapy of Childhood Lymphoma
Status: Not yet recruiting Condition: Non-Hodgkin Lymphoma

Management of Atrial Fibrillation With Flecainide : the AFFLEC Study
Status: Recruiting Condition: Atrial Fibrillation

A Study of Neoadjuvant Bio-chemotherapy (Bio-C/T) Followed by Concurrent Bio-radiotherapy (Bio-R/T) in High-risk Locally Advanced Oral Squamous Cell Carcinoma (OSCC)
Status: Recruiting Condition: Oral Cancer

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
erythromycin stearate
Tablet; Oral062089-002Approved prior to Jan 1, 1982DISCNNo<disabled><disabled>
Parke Davis
erythromycin stearate
Tablet; Oral062032-001Approved prior to Jan 1, 1982DISCNNo<disabled><disabled>
erythromycin stearate
Tablet; Oral061591-001Approved prior to Jan 1, 1982RXNo<disabled><disabled>
erythromycin stearate
Tablet; Oral060359-003Approved prior to Jan 1, 1982RXYes<disabled><disabled>
erythromycin stearate
Tablet; Oral061791-002Approved prior to Jan 1, 1982DISCNNo<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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