Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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
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 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/22/2018 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s068,020090s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019949Orig1s068,020090Orig1s049ltr.pdf
10/27/2017 SUPPL-67 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/2017/019949s067,020090s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019949Orig1s067,020090Orig1s048ltr.pdf
02/07/2019 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019949s065,020090s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019949Orig1s065, 020090Orig1s047ltr.pdf
03/09/2018 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s064,020090s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019949Orig1s064,020090Orig1s046ltr.pdf
06/06/2016 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

05/02/2016 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

05/29/2015 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019949Orig1s060,020090orig1s044ltr.pdf
07/28/2014 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

03/24/2014 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
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-57 Labeling, 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-55 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-52 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-51 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf
08/05/2010 SUPPL-48 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-41 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-37 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-35 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-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19949slr033,19950slr033,20090slr015ltr.pdf
10/07/2004 SUPPL-32 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-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/2004 SUPPL-30 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
03/01/2000 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/27/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/22/1999 SUPPL-27 Labeling

Label is not available on this site.

02/18/1998 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1997 SUPPL-25 Labeling

Label is not available on this site.

02/19/1997 SUPPL-24 Labeling

Label is not available on this site.

05/02/1997 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/06/1996 SUPPL-22 Labeling

Label is not available on this site.

07/23/1996 SUPPL-19 Labeling

Label is not available on this site.

09/11/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/11/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1994 SUPPL-15 Labeling

Label is not available on this site.

05/24/1995 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/23/1994 SUPPL-12 Efficacy-New Patient Population

Label is not available on this site.

10/13/1993 SUPPL-8 Labeling

Label is not available on this site.

06/14/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1993 SUPPL-6 Labeling

Label is not available on this site.

12/30/1993 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

10/13/1993 SUPPL-2 Labeling

Label is not available on this site.

08/20/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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 Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf
09/13/2013 SUPPL-57 Labeling-Package Insert 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

DIFLUCAN

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUCAN FLUCONAZOLE 50MG TABLET;ORAL Prescription Yes AB 019949 PFIZER
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 077731 AUROBINDO PHARMA
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076665 CHARTWELL
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076658 DR REDDYS LABS INC
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 077253 GLENMARK GENERICS
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 078423 HARRIS PHARM
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076077 IVAX SUB TEVA PHARMS
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076351 MYLAN
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076507 TARO
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 074681 TEVA
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076957 UNIQUE PHARM LABS
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 208963 ZYDUS PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUCAN FLUCONAZOLE 100MG TABLET;ORAL Prescription Yes AB 019949 PFIZER
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 077731 AUROBINDO PHARMA
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076665 CHARTWELL
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076658 DR REDDYS LABS INC
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 077253 GLENMARK GENERICS
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 078423 HARRIS PHARM
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076077 IVAX SUB TEVA PHARMS
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076351 MYLAN
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076507 TARO
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 074681 TEVA
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076957 UNIQUE PHARM LABS
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 208963 ZYDUS PHARMS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUCAN FLUCONAZOLE 200MG TABLET;ORAL Prescription Yes AB 019949 PFIZER
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 077731 AUROBINDO PHARMA
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076665 CHARTWELL
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076658 DR REDDYS LABS INC
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 077253 GLENMARK GENERICS
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 078423 HARRIS PHARM
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076077 IVAX SUB TEVA PHARMS
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076351 MYLAN
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076507 TARO
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 074681 TEVA
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076957 UNIQUE PHARM LABS
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 208963 ZYDUS PHARMS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUCAN FLUCONAZOLE 150MG TABLET;ORAL Prescription Yes AB 019949 PFIZER
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 077731 AUROBINDO PHARMA
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076665 CHARTWELL
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076658 DR REDDYS LABS INC
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 077253 GLENMARK GENERICS
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 078423 HARRIS PHARM
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076077 IVAX SUB TEVA PHARMS
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076351 MYLAN
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076507 TARO
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 074681 TEVA
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076957 UNIQUE PHARM LABS
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 208963 ZYDUS PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English