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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019949
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLUCAN FLUCONAZOLE 50MG TABLET;ORAL Prescription AB Yes No
DIFLUCAN FLUCONAZOLE 100MG TABLET;ORAL Prescription AB Yes No
DIFLUCAN FLUCONAZOLE 200MG TABLET;ORAL Prescription AB Yes Yes
DIFLUCAN FLUCONAZOLE 150MG TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/09/2022 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019949Orig1s071,019950Orig1s070,020090Orig1s052lbl.pdf
10/25/2021 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019949s070,019950s069,020090s051lbledt.pdf
09/08/2020 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019949s069,019950s068lbl.pdf
02/07/2019 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019949s065,020090s047lbl.pdf
03/09/2018 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s064,020090s046lbl.pdf
01/22/2018 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s068,020090s049lbl.pdf
10/27/2017 SUPPL-67 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019949s067,020090s048lbl.pdf
10/30/2014 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf
03/24/2014 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf
09/13/2013 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf
09/13/2013 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf
11/16/2011 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf
06/06/2011 SUPPL-51 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s051lbl.pdf
04/26/2011 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf
08/05/2010 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf
03/31/2008 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf
10/07/2004 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf
10/07/2004 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf
10/07/2004 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf
03/24/2004 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf
08/07/2002 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf
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