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Profile for Tradename: METROGEL-VAGINAL

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Metrogel-vaginal is a drug marketed by Medicis and is included in one NDA. It is available from six suppliers.

The generic ingredient in METROGEL-VAGINAL is metronidazole. There are eighteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for Tradename: METROGEL-VAGINAL

Suppliers / Packagers: see list7

Pharmacology for Tradename: METROGEL-VAGINAL

Clinical Trials for: METROGEL-VAGINAL

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

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

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

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

Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
Status: Completed Condition: Hemorrhoids

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

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

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

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
GEL;VAGINAL020208-001Aug 17, 1992RXYes<disabled><disabled>
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Expired Patents for Tradename: METROGEL-VAGINAL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GEL;VAGINAL020208-001Aug 17, 19924,837,378<disabled>
GEL;VAGINAL020208-001Aug 17, 19925,536,743<disabled>
GEL;VAGINAL020208-001Aug 17, 19925,840,744<disabled>
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Paragraph IV activity for: METROGEL-VAGINAL

Drugname Dosage Strength RLD Submissiondate
metronidazoleVaginal Gel0.75%MetroGel-Vaginal9/2/2004
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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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