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OSP finalist
Action period
  1. Other Review

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 860rig15000 OTHER...
    • ...Division of Antiviral Products REGULATORY PROJECT MANAGER LABELING REVIEW Application: NDA 205786 NDA 22145 S-031 NDA 203045 S-009 Name of Drug...
  2. Summary Review

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 860rig15000 SUMMARY REVIEW...
    • ...Cross-Discipline Team Leader Review Date December 4, 2013 From Yodit Belew, MD. Subject Cross-Discipline Team Leader Review DA NDA...
  3. Letter

    Action date:
    FDA Application:
    NDA205777
    Drug:
    Targiniq
    Active Ingredients:
    Naloxone hydrochloride; oxycodone hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205777/S-003 SUPPLEMENT APPROVAL Purdue Pharma, L.P...
    • ...NDA 205777/S-003 Page 2 2. Addition of information to the titration recommendations of OxyContin for adult patients 3. Product-specific information...
  4. Letter

    Action date:
    FDA Application:
    NDA205777
    Drug:
    Targiniq
    Active Ingredients:
    Naloxone hydrochloride; oxycodone hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205777/S-002 SUPPLEMENT APPROVAL REMS ASSESSMENT...
    • ...NDA 205777/S-002 Page 2 1. Product-specific information for a recently approved ER/LA opioid analgesic, Hysingla ER (hydrocodone bitartrate extended...
  5. Letter

    Action date:
    FDA Application:
    NDA205777
    Drug:
    Targiniq
    Active Ingredients:
    Naloxone hydrochloride; oxycodone hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205777/S-001 SUPPLEMENT APPROVAL Purdue Pharma L.P...
    • ...NDA 205777/S-001 Page 2 iv. Revisions to the Blueprint to incorporate updated product-specific titration language. Changes to the ER/LA Opioid...
  6. Label

    Action date:
    FDA Application:
    NDA205776
    Drug:
    Rasuvo
    Active Ingredients:
    Methotrexate
    • ...• HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RASUVO® safely and effectively. See full...
    • ...6 7 8 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Other Adverse Reactions DRUG INTERACTIONS 7.1 Aspirin, Nonsteroidal Anti-Inflammatory...
  7. Letter

    Action date:
    FDA Application:
    NDA205776
    Drug:
    Rasuvo
    Active Ingredients:
    Methotrexate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205776/S-001 SUPPLEMENT APPROVAL Medac Pharma, Inc...
    • ...NDA 205776/S-001 Page 2 http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf The SPL will be accessible...
  8. Label

    Action date:
    FDA Application:
    NDA205776
    Drug:
    Rasuvo
    Active Ingredients:
    Methotrexate
    • ...• HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use. RASUVO™ safely and effectively. See full...
    • ...6 7 8 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Other Adverse Reactions DRUG INTERACTIONS 7.1 Aspirin, Nonsteroidal Anti-Inflammatory...
  9. Letter

    Action date:
    FDA Application:
    NDA205776
    Drug:
    Rasuvo
    Active Ingredients:
    Methotrexate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205776 NDA APPROVAL Medac Pharma, Inc. c/o B&H...
    • ...NDA 205776 Page 2 WAIVER OF HIGHLIGHTS SECTION We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights...
  10. Letter

    Action date:
    FDA Application:
    NDA205767
    Drug:
    Oxygen, usp
    Active Ingredients:
    Oxygen
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205767 NADA 141365 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205767 NADA 141365 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...