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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205649/S-004 SUPPLEMENT APPROVAL AstraZeneca...
    • ...NDA 205649/S-004 Page 2 of labeling must be identical to the enclosed labeling (text for the package insert, Medication Guide), with the addition...
  2. Label

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full...
    • ...5.14 Vitamin B12 Concentrations 5.15 Genital Mycotic Infections 5.16 Increases in Low-Density Lipoprotein Cholesterol (LDL-C) 5.17 Bladder Cancer 5.18...
  3. Letter

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205649/S-003 SUPPLEMENT APPROVAL AstraZeneca AB c/o...
    • ...NDA 205649/S-003 Page 2 WAIVER OF HIGHLIGHTS SECTION Please note that we have previously granted a waiver of the requirements of 21 CFR 201.57(d)(8...
  4. Label

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full...
    • ...14 8.4 8.5 8.6 10 11 12 13 Pediatric Use Geriatric Use Patients with Mild Renal Impairment (eGFR ≥60 to <90 mL/min/1.73 m2) OVERDOSAGE...
  5. Letter

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205649 NDA APPROVAL AstraZeneca AB Attention: Mike...
    • ...NDA 205649 Page 2 Guide. Information on submitting SPL files using eLIST may be found in the guidance for industry SPL Standard for Content...
  6. Summary Review

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2056490rig15000 SUMMARY REVIEW...
    • ...Cross-Discipline Team Leader Review NDA 205649 Xigduo (dapagli?ozin plus metformin hydrochloride ?xed-dose combination) Cross-Discipline Team Leader...
  7. Letter

    Action date:
    FDA Application:
    NDA205645
    Drug:
    Tigecycline
    Active Ingredients:
    Tigecycline
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205645 TENTATIVE APPROVAL Fresenius Kabi, USA, LLC...
    • ...NDA 205645 Page 2 Section 505(c)(3)(C) of the Act provides that approval of a new drug application submitted pursuant to section 505(b)(2) of the Act...
  8. Label

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DULERA safely and effectively. See full...
    • ...5.3 6 7 Excessive Use of DULERA and Use with Other Long-Acting Beta2-Agonists 5.4 Local Effects 5.5 Immunosuppression 5.6 Transferring Patients...
  9. Letter

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 022518/S-019 NDA 205641/S-005 SUPPLEMENT APPROVAL...
    • ...NDA 022518/S-019 NDA 205641/S-005 Page 2 Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed labeling...
  10. Label

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ... HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ASMANEX HFA safely and effectively. See...
    • ...17 16.1 How Supplied 16.2 Storage and Handling PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information...