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Details for Generic Name: metronidazole

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Metronidazole is the generic ingredient in eighteen branded drugs marketed by Gd Searle Llc, Able, Alembic Ltd, Par Pharm, Galderma Labs Lp, Fougera Pharms, G And W Labs, Valeant Bermuda, G And W Labs Inc, Taro, Tolmar, Medicis, Watson Labs Inc, Teva Pharms, Baxter Hlthcare, Pfizer, B Braun, Abbott, Abraxis Pharm, Hikma Maple , Intl Medication, Watson Labs, Claris Lifesciences, Hospira, Labs Af, Alembic Pharms Ltd, Halsey, Ivax Sub Teva Pharms, LNK, Mutual Pharm, Pliva, Sandoz, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Vivimed Labs, Ortho Mcneil Pharm, and Savage Labs, and is included in sixty-six NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for metronidazole. Twenty suppliers are listed for this compound.

Summary for Generic Name: metronidazole

Tradenames:18
Patents:4
Applicants:38
NDAs:66
Drug Master File Entries: see list18
Suppliers: see list20
Therapeutic Class:Antibacterials

Pharmacology for Ingredient: metronidazole

Clinical Trials for: metronidazole

A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis
Status: Completed Condition: Clostridium Difficile Associated Diarrhea

Penicillin and Metronidazole in Treatment of Peritonsillar Abscess
Status: Completed Condition: Peritonsillar Abscess

A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately
Status: Completed Condition: Healthy

Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
Status: Recruiting Condition: Abnormal Vaginal Flora; Clindamycin Vs Metronidazole; High Risk Pregnancies for Preterm Labor

A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Status: Completed Condition: Intra-abdominal Infections

Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
Status: Recruiting Condition: Clostridium Difficile Diarrhea

Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Status: Completed Condition: Bacterial Vaginosis; Candidiasis; Trichomoniasis

Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Status: Completed Condition: Healthy

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease
Status: Recruiting Condition: Crohn's Disease

Metronidazole Pharmacokinetics (PK) in Premature Infants
Status: Completed Condition: Serious Systemic Infections; Necrotizing Enterocolitis

Radiotherapy + Metronidazole vs Radiotherapy Alone In Improving Treatment Outcomes in Advanced Cervical Cancer in Uganda
Status: Completed Condition: Cervix Carcinoma

A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
Status: Completed Condition: Helicobacter Infections

Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections
Status: Not yet recruiting Condition: Bacterial Vaginosis; Fungal Vaginal Infections

Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
Status: Completed Condition: Bacterial Vaginosis

A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects
Status: Completed Condition: Infection

Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections
Status: Completed Condition: Complicated Intra-abdominal Infection

Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis
Status: Completed Condition: Chronic Periodontitis

Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia
Status: Completed Condition: Helicobacter Pylori Infection

Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
Status: Completed Condition: Chronic Periodontitis

Treatment Study of Metronidazole to Treat Dientamoebiasis in Children
Status: Completed Condition: Dientamoebiasis

Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy
Status: Recruiting Condition: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease
Status: Completed Condition: Crohn's Disease

CD5024 1% Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
Status: Completed Condition: Papulopustular Rosacea

BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study
Status: Recruiting Condition: Bacterial Vaginosis

Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
Status: Completed Condition: Healthy

Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Status: Completed Condition: Complicated Intra-Abdominal Infection

Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
Status: Recruiting Condition: Complicated Intra-abdominal Infection

Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
Status: Completed Condition: Clostridium Enterocolitis; Antibiotic-Associated Diarrhea; Pseudomembranous Colitis; Pseudomembranous Enterocolitis; Pseudomembranous Enteritis

An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
Status: Completed Condition: Rosacea

Alternative Antibiotic Regime in the Treatment of GAgP
Status: Completed Condition: Generalized Aggressive Periodontitis; Aggressive Periodontitis

MTZ Plus AMX in the Treatment of Smokers and Non-smokers
Status: Completed Condition: Chronic Periodontitis; Smoking

Study of Antibiotics in the Treatment of Colonic Crohn's Disease
Status: Terminated Condition: Crohn's Disease

Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication
Status: Recruiting Condition: Dyspepsia; Peptic Ulcer

Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.
Status: Recruiting Condition: Chronic Periodontitis; Clinical and Microbiological Effects

Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Status: Recruiting Condition: Abscess, Intra-Abdominal

A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea
Status: Completed Condition: Rosacea

Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis
Status: Recruiting Condition: Bacterial Vaginosis

A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
Status: Completed Condition: Pelvic Inflammatory Disease

A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
Status: Completed Condition: Primary Sclerosing Cholangitis

Impact of Oral Antibiotic Treatment on C. Difficile
Status: Recruiting Condition: C. Difficile; Diarrhea; Enterocolitis

A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy
Status: Completed Condition: Haemorrhoidectomy

Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
Status: Completed Condition: Infection Prophylaxis in Colo Rectal Surgery

Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea
Status: Completed Condition: Papulopustular Rosacea

A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
Status: Completed Condition: Intra-abdominal Infection

Metronidazole for Pulmonary Tuberculosis (South Korea)
Status: Completed Condition: Tuberculosis; Multi-Drug Resistant Tuberculosis

Do Motion Metrics Lead to Improved Skill Acquisition on Simulators?
Status: Completed Condition: Performance Assessment; Motion Metrics

A Study Comparing Ceftazidime-Avibactam+Metronidazole Versus Meropenem in Adults With Complicated Intra-abdominal Infections
Status: Completed Condition: Complicated Intra-Abdominal Infection

Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
Status: Completed Condition: Skin Manifestations

Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin
Status: Completed Condition: Skin Manifestations

Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
Status: Completed Condition: Infection; Surgical Site Infection

Inflammation and Treatment of Bacterial Vaginosis Near Term
Status: Recruiting Condition: Bacterial Vaginosis

The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis
Status: Recruiting Condition: Periodontal Pocket

Safety and Efficacy of Single Daily Dose of Ceftriaxone and Metronidazole for Treatment of Complicated Appendicitis in Children
Status: Completed Condition: Complicated Appendicitis

A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
Status: Active, not recruiting Condition: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
Status: Completed Condition: Bacterial Vaginosis

Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
Status: Completed Condition: Rosacea

Bioavailability Study of Metronidazole Capsules Under Fed Conditions
Status: Completed Condition: To Determine the Bioequivalence Study Under Fed

Bioavailability Study of Metronidazole Capsules Under Fasting Conditions
Status: Completed Condition: To Determine the Bioequivalence Study Under Fasting

Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.
Status: Completed Condition: Bacterial Infections

Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Status: Completed Condition: Helicobacter Infections

Docetaxel and Prednisone With or Without Vaccine in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Status: Active, not recruiting Condition: Adenocarcinoma of the Prostate; Castrate-resistant Metastatic Prostate Cancer

The Impact of Obesity on Nonsurgical Periodontal Therapy
Status: Recruiting Condition: Periodontitis; Periodontal Diseases; Obesity

Prevention of Persistence of Bacterial Vaginosis
Status: Terminated Condition: Bacterial Vaginosis

Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
Status: Completed Condition: Vaginosis, Bacterial; Vaginal Infection

Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
Status: Completed Condition: Rosacea

Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Status: Not yet recruiting Condition: Chronic Blepharitis

Cortical Metrics in Intervention Trials With Autism Spectrum Disorders
Status: Recruiting Condition: Autism Spectrum Disorders

IMT for Primary Clostridium Difficile Infection
Status: Not yet recruiting Condition: Clostridium Difficile Infection

Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
Status: Completed Condition: Perianal Crohns'

Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
Status: Completed Condition: Breast Cancer; Colorectal Cancer; Gallbladder Cancer; Gastric Cancer; Head and Neck Cancer; Liver Cancer; Ovarian Cancer; Pancreatic Cancer; Testicular Germ Cell Tumor

Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer
Status: Active, not recruiting Condition: Rectal Cancer

Randomized Controlled Trial of Treatment of Male Partners of Women With BV
Status: Not yet recruiting Condition: Recurrent Bacterial Vaginosis

A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
Status: Completed Condition: Vaginitis; Infectious Vaginosis

Safety and Tolerability of a Modified Vaccinia Ankara (MVA)-Based Vaccine Modified to Express Brachyury and T-cell Costimulatory Molecules (MVA-Brachyury-TRICOM)
Status: Recruiting Condition: Lung Cancer; Breast Cancer; Prostate Cancer; Tumors (Others)

Trichomonas Vaginalis Recurrence Among HIV+ Women
Status: Completed Condition: Trichomonas Infections; HIV Infections

Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
Status: Completed Condition: Healthy

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
Status: Completed Condition: Appendicitis; Cholecystitis; Diverticulitis; Intra-Abdominal Abscess; Intra-Abdominal Infection; Peritonitis

153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer
Status: Completed Condition: Prostate Cancer

Antibiotic Safety (SCAMP)
Status: Recruiting Condition: Complicated Intra Abdominal Infections

Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis
Status: Recruiting Condition: Pancreatitis,Acute Necrotizing

Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)
Status: Recruiting Condition: Postoperative Ileus

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Status: Completed Condition: Appendicitis; Cholecystitis; Cross Infection; Diverticulitis; Peritonitis

Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population
Status: Recruiting Condition: Vaginosis, Bacterial; Infertility; Miscarriage

Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori
Status: Completed Condition: Helicobacter Pylori Infection

Response of Clostridium Difficile Infection to Metronidazole Therapy
Status: Completed Condition: Clostridium Enterocolitis; Pseudomembranous Colitis; Antibiotic-Associated Colitis

MATER Study: A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
Status: Completed Condition: Non-Small Cell Lung Cancer

Bimetric-10: Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-Metric Stem
Status: Completed Condition: Osteoarthrosis

Effects and Safety of Metronidazole in Patients With Gastrectomy
Status: Active, not recruiting Condition: Post Gastrectomy State

Multi-Center Study of New Medications to Treat Vaginal Infections
Status: Not yet recruiting Condition: Vaginal Infection

Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy
Status: Recruiting Condition: Helicobacter Pylori Infection

Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)
Status: Active, not recruiting Condition: Adult Solid Neoplasm

Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Status: Completed Condition: Bacterial Vaginosis

Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
Status: Completed Condition: Rosacea

Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis
Status: Active, not recruiting Condition: Periodontitis

A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis
Status: Terminated Condition: Appendicitis

Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer
Status: Terminated Condition: Extensive Stage Small Cell Lung Cancer; Recurrent Colon Cancer; Recurrent Non-small Cell Lung Cancer; Recurrent Rectal Cancer; Recurrent Small Cell Lung Cancer; Stage IV Colon Cancer; Stage IV Non-small Cell Lung Cancer; Stage IV Rectal Cancer

Is it Effective to Treat Patients With Blastocystis Hominis Infection?
Status: Recruiting Condition: Blastocystis Hominis Infections

Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other
Status: Completed Condition: Oral Lichen Planus

LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
Status: Recruiting Condition: Bacterial Vaginosis (BV)

The Use of Antibiotics After Hospital Discharge in Septic Abortion
Status: Terminated Condition: Abortion, Septic

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Labs Af
METROMIDOL
metronidazole
TABLET;ORAL074523Oct 24, 1996DISCNNo<disabled><disabled>
Watson Labs Inc
METRONIDAZOLE
metronidazole
GEL;VAGINAL205223Mar 24, 2014RXYes<disabled><disabled>
Lnk
METRONIDAZOLE
metronidazole
TABLET;ORAL019029Apr 10, 1984DISCNNo<disabled><disabled>
Ortho Mcneil Pharm
PROTOSTAT
metronidazole
TABLET;ORAL018871Mar 2, 1983DISCNNo<disabled><disabled>
Watson Labs Inc
METRONIDAZOLE
metronidazole
TABLET;ORAL070044Feb 8, 1985RXNo<disabled><disabled>
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