Disclaimer: This is an early beta prototype. If you find any error, with data or functionality, please let us know via this page.
OSP finalist
Open Knowledge
Advanced search
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...