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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA207923
    Drug:
    Seebri
    Active Ingredients:
    Glycopyrrolate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SEEBRI NEOHALER safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE SEEBRI™ NEOHALER® is indicated for the long-term, maintenance treatment of airflow obstruction...
  2. Letter

    Action date:
    FDA Application:
    NDA207923
    Drug:
    Seebri
    Active Ingredients:
    Glycopyrrolate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207923 NDA APPROVAL Novartis Pharmaceuticals...
    • ...NDA 207923 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  3. Label

    Action date:
    FDA Application:
    NDA207920
    Drug:
    Nexium 24hr
    Active Ingredients:
    Esomeprazole magnesium
    • ...NO COPY 1/16" (0.0625") IN FROM DIE (DASH LINE DOES NOT PRINT) PAA058427.FDA03 1/4" HINGE AREA UNVARNISHED (LINES DO NOT PRINT) BASE PANEL 3...
    • ...PRODUCTION Job Information • DRUG FACTS TITLE DRUG FACTS TEXT DEFINED 9 pt • DRUG FACTS CONTINUED 8 pt • HEADINGS 8 pt • SUBHEADINGS/BODY TEXT...
  4. Letter

    Action date:
    FDA Application:
    NDA207920
    Drug:
    Nexium 24hr
    Active Ingredients:
    Esomeprazole magnesium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207920 NDA APPROVAL Pfizer, Inc. Attention: Christine...
    • ...NDA 207920 Page 2 DRUG REGISTRATION AND LISTING All drug establishment registration and drug listing information is to be submitted to FDA...
  5. Summary Review

    Action date:
    FDA Application:
    NDA207920
    Drug:
    Nexium 24hr
    Active Ingredients:
    Esomeprazole magnesium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 9200rig15000 SUMMARY REVIEW...
    • ...Deputy Division Director Summary Review NDA 207920...
  6. Label

    Action date:
    FDA Application:
    NDA207917
    Drug:
    Epiduo forte
    Active Ingredients:
    Adapalene; benzoyl peroxide
    • ...Page 1 of 7 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EPIDUO FORTE gel safely...
    • ...Page 2 of 7 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE EPIDUO FORTE gel is indicated for the topical treatment of acne vulgaris . 2...
  7. Letter

    Action date:
    FDA Application:
    NDA207917
    Drug:
    Epiduo forte
    Active Ingredients:
    Adapalene; benzoyl peroxide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207917 NDA APPROVAL Galderma Research and Development...
    • ...NDA 207917 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  8. Label

    Action date:
    FDA Application:
    NDA207916
    Drug:
    Cetylev
    Active Ingredients:
    Acetylcysteine
    • ... See the Full Prescribing Information for instructions on how to use the nomogram to determine the need for loading and maintenance dosing...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE CETYLEV is indicated to prevent or lessen hepatic injury after ingestion of a potentially...
  9. Letter

    Action date:
    FDA Application:
    NDA207916
    Drug:
    Cetylev
    Active Ingredients:
    Acetylcysteine
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207916 NDA APPROVAL Arbor Pharmaceuticals, LLC...
    • ...NDA 207916 Page 2 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL will be accessible via...
  10. Label

    Action date:
    FDA Application:
    NDA207865
    Drug:
    Emend
    Active Ingredients:
    Aprepitant
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EMEND CAPSULES and EMEND FOR ORAL SUSPENSION...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) 1.2...