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Profile for Tradename: PEPCID COMPLETE

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Pepcid Complete is a drug marketed by Mcneil Cons and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and forty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for Tradename: PEPCID COMPLETE

Patents:2
Applicants:1
NDAs:1
Suppliers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: PEPCID COMPLETE

Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)
Status: Completed Condition: Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain

A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer
Status: Completed Condition: Cancer

Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
Status: Recruiting Condition: Aspirin; Dyspepsia

Ruxolitinib W/ Preop Chemo For Triple Negative Inflammatory Brca
Status: Recruiting Condition: Recurrent Breast Cancer; Metastatic Breast Cancer

Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Status: Recruiting Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Courtesy of ClinicalTrials.org
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
Mcneil Cons
PEPCID COMPLETE
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 2000OTCYes6,814,978*PED<disabled>Y<disabled>
Mcneil Cons
PEPCID COMPLETE
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 2000OTCYes5,989,588*PED<disabled>Y<disabled>
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Paragraph IV activity for: PEPCID COMPLETE

Drugname Dosage Strength RLD Submissiondate
calcium carbonate/ famotadine/ magnesium hydroxideChewable Tablets800 mg/ 10 mg/ 165 mg (OTC)Pepcid Complete11/1/2004
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Preferred citation:

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

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