Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
07/12/2023 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019949s074,020090s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019949Orig1s074;019950Orig1s073;020090Orig1s055ltr.pdf | |
01/17/2023 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019949s073,020090s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019949Orig1s073;019950Orig1s072;020090Orig1s054ltr.pdf | |
02/12/2024 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019949s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019949Orig1s072; 019950Orig1s071; 020090Orig1s053ltr.pdf | |
03/09/2022 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019949Orig1s071,019950Orig1s070,020090Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019949Orig1s071, 019950Orig1s070, 020090Orig1s052ltr.pdf | |
10/25/2021 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019949s070,019950s069,020090s051lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019949Orig1s070; 019950Orig1s069; 020090Orig1s051ltr.pdf | |
09/08/2020 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019949s069,019950s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019949Orig1s069,019950Orig1s068,020090Orig1s050ltr.pdf | |
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 |
---|---|---|---|---|---|
02/12/2024 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019949s072lbl.pdf | |
07/12/2023 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019949s074,020090s055lbl.pdf | |
01/17/2023 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019949s073,020090s054lbl.pdf | |
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 | 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 | 078423 | ANI PHARMS |
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 PHARMS LTD |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076957 | THINQ PHARM-CRO PVT |
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 | 078423 | ANI PHARMS |
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 PHARMS LTD |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076957 | THINQ PHARM-CRO PVT |
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 | 078423 | ANI PHARMS |
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 PHARMS LTD |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076957 | THINQ PHARM-CRO PVT |
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 | 078423 | ANI PHARMS |
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 PHARMS LTD |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076957 | THINQ PHARM-CRO PVT |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 208963 | ZYDUS PHARMS |