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Summary for Generic Name: darunavir ethanolate
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Clinical Trials for: darunavir ethanolateA Study to Assess the Pharmacokinetics (Blood Levels) of TMC114 (Darunavir) Taken With Ritonavir and/or TMC125 (Etravirine) and TMC278 (Rilpivirine) in HIV-1 Infected Pregnant Women Status: Recruiting Condition: HIV; HIV Infections; Pregnancy TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients Status: Completed Condition: HIV Infections An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients Status: Completed Condition: Human Immunodeficiency Virus (HIV) Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects Status: Completed Condition: HIV Infections TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Adults Coming From Any of the Three Ongoing Tibotec-Sponsored Studies With DRV Status: Active, not recruiting Condition: HIV-1 Infections Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults Status: Active, not recruiting Condition: Acquired Immunodeficiency Syndrome; HIV Infections DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects Status: Recruiting Condition: HIV Darunavir/Ritonavir and Rosuvastatin Pharmacokinetic Study Status: Active, not recruiting Condition: HIV Infections A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions Status: Completed Condition: Healthy Participants Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz Status: Active, not recruiting Condition: Hyperlipidemia; HIV Courtesy of ClinicalTrials.org See more clinical trials for this drug | |||||||||||||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Product | Substance | Delist_Flag | Patent Expiration | Patented / Exclusive Use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Janssen Prods | PREZISTA | darunavir ethanolate | TABLET; ORAL | 021976 | Nov 9, 2012 | RX | Yes | <disabled> | UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET; ORAL | 021976 | Nov 9, 2012 | RX | Yes | <disabled> | PEDIATRIC EXCLUSIVITY | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET; ORAL | 021976 | Nov 9, 2012 | RX | Yes | <disabled> | NEW PATIENT POPULATION | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Janssen Prods | PREZISTA | darunavir ethanolate | TABLET; ORAL | 021976 | Nov 9, 2012 | RX | Yes | <disabled> | 800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1 INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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