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OSP finalist
Action period
  1. Administrative Document & Correspondence

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205786Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS...
    • ...EXCLUSIVITY SUMMARY NDA # 205786 SUPPL # Original HFD # 530 Trade Name Isentress for oral suspension Generic Name raltegravir Applicant Name Merck...
  2. Approval Letter

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 205786Orig1s000 Trade Name: ISENTRESS® for oral suspension, 100 mg...
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH 205786Orig1s000 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter Other Action...
  3. Clinical Pharmacology Biopharmaceutics Review

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205786Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S...
    • ...OFFICE OF CLINICAL PHARMACOLOGY CLINICAL PHARMACOLOGY SECONDARY REVIEW 205786. 203045 S-009. 22145 S-031 Date of Original Submission: June...
  4. Chemistry Review

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205786Orig15000 CHEMISTRY...
    • ...ONDQA Quality Assessment Division II NDA 22-145 S-031 DS-865) Isentress NDA 203-045 S-009 SD-60) Merck NDA 205-786 Original Submission Dates: June...
  5. Officer/Employee List

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205786Orig1s000 MICROBIOLOGY / VIROLOGY REVIEW(S...
    • ...DIVISION OF ANTIVIRAL PRODUCTS (HFD-530) VIROLOGY REVIEW NDA: 205-786 SDN: 001 DATE REVIEWED: 10/30/13 Clinical Virology Reviewer: Sung S. Rhee, Ph.D...
  6. Label

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full...
    • ...14.3 Pediatric Subjects 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 12.4 Microbiology 13 NONCLINICAL TOXICOLOGY 13.1...
  7. Printed Labeling

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 860rig15000 LABELING...
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full...
  8. Letter

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205786 NDA 22145 S-031 NDA 203045 S-009 NDA APPROVAL...
    • ...NDA 205786 NDA 22145 S-031 NDA 203045 S-009 Page 2 These Prior Approval supplemental new drug applications update the shared ISENTRESS® (raltegravir...
  9. Medical Review

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 860rig15000 MEDICAL...
    • ...CLINICAL REVIEW Application Type Application Number(s) Priority or Standard Submit Date(s) Received Date(s) PDUFA Goal Date Division Office...
  10. Microbiology Review

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205786Orig1s000 MICROBIOLOGY / VIROLOGY REVIEW(S...
    • ...DIVISION OF ANTIVIRAL PRODUCTS (HFD-530) VIROLOGY REVIEW NDA: 205-786 SDN: 001 DATE REVIEWED: 10/30/13 Clinical Virology Reviewer: Sung S. Rhee, Ph.D...