Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019950
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
DIFLUCAN IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
DIFLUCAN IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/29/1990 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/07/2019 SUPPL-67 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019950Orig1s066, s067ltr.pdf
11/07/2019 SUPPL-66 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019950Orig1s066, s067ltr.pdf
06/01/2015 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

07/28/2014 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

03/24/2014 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (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/2014/019949s058,019950s062,020090s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1sS058,019950Orig1sS062,020090Orig1s042ltr.pdf
09/13/2013 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019949s057,019950s061,020090s040ltr.pdf
11/16/2011 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s055,019950s059,020090s038ltr.pdf
04/26/2011 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s052,019950s057,020090s036ltr.pdf
06/06/2011 SUPPL-56 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019950s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf
08/05/2010 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019949s048,019950s053,020090s031ltr.pdf
03/31/2008 SUPPL-43 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019949s041,019950s043,020090s022ltr.pdf
03/24/2004 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949slr037,19950slr039,20090slr019ltr.pdf
10/07/2004 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf
08/07/2002 SUPPL-34 Labeling

Label is not available on this site.

10/07/2004 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf
03/05/2001 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/2004 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19949s30,32,35,19950s31,33,37,20090s12,14,17ltr.pdf
09/29/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/29/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/22/1999 SUPPL-28 Labeling

Label is not available on this site.

02/13/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/05/1997 SUPPL-26 Labeling

Label is not available on this site.

02/19/1997 SUPPL-25 Labeling

Label is not available on this site.

08/06/1996 SUPPL-24 Labeling

Label is not available on this site.

07/23/1996 SUPPL-22 Labeling

Label is not available on this site.

12/22/1995 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1995 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1995 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1994 SUPPL-18 Labeling

Label is not available on this site.

08/22/1994 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1994 SUPPL-16 Efficacy-New Patient Population

Label is not available on this site.

07/08/1994 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/22/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/13/1993 SUPPL-10 Labeling

Label is not available on this site.

02/10/1993 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1993 SUPPL-7 Labeling

Label is not available on this site.

12/30/1993 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

10/13/1993 SUPPL-3 Labeling

Label is not available on this site.

09/29/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2014 SUPPL-62 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/2014/019949s058,019950s062,020090s042lbl.pdf
09/13/2013 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf
11/16/2011 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf
06/06/2011 SUPPL-56 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019950s056lbl.pdf
04/26/2011 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf
08/05/2010 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf
03/31/2008 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf
10/07/2004 SUPPL-37 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-33 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-31 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-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf

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