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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA208434
    Drug:
    Alecensa
    Active Ingredients:
    Alectinib hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALECENSA safely and effectively. See full...
    • ...1 FULL PRESCRIBING INFORMATION 2 3 1 INDICATIONS AND USAGE 4 5 ALECENSA is indicated for the treatment of patients with anaplastic lymphoma...
  2. Summary Review

    Action date:
    FDA Application:
    NDA208434
    Drug:
    Alecensa
    Active Ingredients:
    Alectinib hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2084340rig15000 SUMMARY REVIEW...
    • ...Division Director Summary Review for Regulatory Action Date December 9, 2015 From Patricia Keegan Subject Division Director...
  3. Label

    Action date:
    FDA Application:
    NDA208424
    Drug:
    Gonitro
    Active Ingredients:
    Nitroglycerin
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GONITRO safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE GONITRO is indicated for acute relief of an attack or prophylaxis of angina pectoris due...
  4. Letter

    Action date:
    FDA Application:
    NDA208424
    Drug:
    Gonitro
    Active Ingredients:
    Nitroglycerin
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208424 NDA APPROVAL G. Pohl Boskamp GmbH & Co. KG c/o...
    • ...NDA 208424 Page 2 Marketing the product with FPL that is not identical to the approved labeling text may render the product misbranded...
  5. Label

    Action date:
    FDA Application:
    NDA208411
    Drug:
    Narcan
    Active Ingredients:
    Naloxone hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NARCAN NASAL SPRAY safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 12.1...
  6. Letter

    Action date:
    FDA Application:
    NDA208411
    Drug:
    Narcan
    Active Ingredients:
    Naloxone hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 NDA 208411 NDA APPROVAL Adapt Pharma Operations Limited...
    • ...NDA 208411 Page 2 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL will be accessible via...
  7. Label

    Action date:
    FDA Application:
    NDA208401
    Drug:
    Qbrelis
    Active Ingredients:
    Lisinopril
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use QBRELIS safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue QBRELIS as soon as possible [see Warnings...
  8. Letter

    Action date:
    FDA Application:
    NDA208401
    Drug:
    Qbrelis
    Active Ingredients:
    Lisinopril
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208401 NDA APPROVAL Silvergate Pharmaceuticals, Inc...
    • ...NDA 208401 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  9. Label

    Action date:
    FDA Application:
    NDA208351
    Drug:
    Odefsey
    Active Ingredients:
    Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS...
  10. Letter

    Action date:
    FDA Application:
    NDA208351
    Drug:
    Odefsey
    Active Ingredients:
    Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208351 NDA APPROVAL Gilead Sciences, Inc. Attention...
    • ...NDA 208351 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21...