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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA207946
    Drug:
    Invega trinza
    Active Ingredients:
    Paliperidone palmitate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use INVEGA TRINZA™ safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 1  INDICATIONS AND USAGE  2...
  2. Letter

    Action date:
    FDA Application:
    NDA207946
    Drug:
    Invega trinza
    Active Ingredients:
    Paliperidone palmitate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207946 NDA APPROVAL Janssen Pharmaceuticals, Inc...
    • ...NDA 207946 Page 2 We are waiving the current requirements of 21 CFR 201.56(d)(1) and 201.57(c)(9)(i) through (iii), regarding the content and format...
  3. Summary Review

    Action date:
    FDA Application:
    NDA207946
    Drug:
    Invega trinza
    Active Ingredients:
    Paliperidone palmitate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2079460rig15000 SUMMARY REVIEW...
    • ...MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE...
  4. Letter

    Action date:
    FDA Application:
    NDA207932
    Drug:
    Belbuca
    Active Ingredients:
    Buprenorphine hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207932/S-001 SUPPLEMENT APPROVAL Endo...
    • ...NDA 207932/S-001 Page 2 This REMS uses a single, shared system for the elements to assure safe use and the REMS assessments. This single shared...
  5. Label

    Action date:
    FDA Application:
    NDA207931
    Drug:
    Technivie
    Active Ingredients:
    Ombitasvir; paritaprevir; ritonavir
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TECHNIVIE safely and effectively. See full...
    • ...Reference ID: 3948977...
  6. Letter

    Action date:
    FDA Application:
    NDA207931
    Drug:
    Technivie
    Active Ingredients:
    Ombitasvir; paritaprevir; ritonavir
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207931/S-004 SUPPLEMENT APPROVAL AbbVie Inc...
    • ...NDA 207931/S-004 Page 2  Corresponding changes to the Medication Guide for drug-drug interactions and administration APPROVAL & LABELING We...
  7. Label

    Action date:
    FDA Application:
    NDA207931
    Drug:
    Technivie
    Active Ingredients:
    Ombitasvir; paritaprevir; ritonavir
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TECHNIVIE safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TECHNIVIE is indicated in combination with ribavirin for the treatment of patients with genotype...
  8. Letter

    Action date:
    FDA Application:
    NDA207931
    Drug:
    Technivie
    Active Ingredients:
    Ombitasvir; paritaprevir; ritonavir
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207931/S-002 SUPPLEMENT APPROVAL AbbVie Inc...
    • ...NDA 207931/S-002 Page 2 at http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/ UCM072392.pdf The SPL...
  9. Label

    Action date:
    FDA Application:
    NDA207931
    Drug:
    Technivie
    Active Ingredients:
    Ombitasvir; paritaprevir; ritonavir
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TECHNIVIE safely and effectively. See full...
    • ...Reference ID: 3837135...
  10. Letter

    Action date:
    FDA Application:
    NDA207931
    Drug:
    Technivie
    Active Ingredients:
    Ombitasvir; paritaprevir; ritonavir
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207931/S-001 SUPPLEMENT APPROVAL AbbVie Inc...
    • ...NDA 207931/S-001 Page 2 Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed labeling. Information...