Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020090
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIFLUCAN | FLUCONAZOLE | 50MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| DIFLUCAN | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/23/1993 | 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 |
|---|---|---|---|---|---|
| 07/12/2023 | SUPPL-55 | 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-54 | 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-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019950s071,020090s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019949Orig1s072; 019950Orig1s071; 020090Orig1s053ltr.pdf | |
| 03/09/2022 | SUPPL-52 | 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-51 | 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-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020090s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019949Orig1s069,019950Orig1s068,020090Orig1s050ltr.pdf | |
| 01/22/2018 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019949Orig1s068,020090Orig1s049ltr.pdf | |
| 10/27/2017 | SUPPL-48 | 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-47 | 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-46 | 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 | |
| 10/30/2014 | SUPPL-44 | 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-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/2014 | SUPPL-42 | 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 | |
| 01/07/2014 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/2013 | SUPPL-40 | 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-38 | 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-36 | 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-34 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020090s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019949s051,019950s056,020090s034ltr.pdf | |
| 08/05/2010 | SUPPL-31 | 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-22 | 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-19 | 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-17 | 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-15 | 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-14 | 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-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/2004 | SUPPL-12 | 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 | |
| 02/22/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/05/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/19/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/06/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/23/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/22/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/21/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/30/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/22/1994 | SUPPL-1 | Labeling |
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-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019950s071,020090s053lbl.pdf | |
| 07/12/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019949s074,020090s055lbl.pdf | |
| 01/17/2023 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019949s073,020090s054lbl.pdf | |
| 03/09/2022 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019949Orig1s071,019950Orig1s070,020090Orig1s052lbl.pdf | |
| 10/25/2021 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019949s070,019950s069,020090s051lbledt.pdf | |
| 09/08/2020 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020090s050lbl.pdf | |
| 02/07/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019949s065,020090s047lbl.pdf | |
| 03/09/2018 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s064,020090s046lbl.pdf | |
| 01/22/2018 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019949s068,020090s049lbl.pdf | |
| 10/27/2017 | SUPPL-48 | 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-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s060,020090s044lbl.pdf | |
| 03/24/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019949s058,019950s062,020090s042lbl.pdf | |
| 09/13/2013 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019949s057,019950s061,020090s040lbl.pdf | |
| 11/16/2011 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055,019950s059,020090s038lbl.pdf | |
| 06/06/2011 | SUPPL-34 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020090s034lbl.pdf | |
| 04/26/2011 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s052,019950s057,020090s036lbl.pdf | |
| 08/05/2010 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019949s048,019950s053,020090s031lbl.pdf | |
| 03/31/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019949s041,019950s043,020090s022lbl.pdf | |
| 10/07/2004 | SUPPL-17 | 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-14 | 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-12 | 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-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19949slr037,19950slr039,20090slr019_diflucan_lbl.pdf | |
| 08/07/2002 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19949s33lbl.pdf |
DIFLUCAN
FOR SUSPENSION;ORAL; 50MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIFLUCAN | FLUCONAZOLE | 50MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020090 | PFIZER |
| FLUCONAZOLE | FLUCONAZOLE | 50MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 079150 | AUROBINDO PHARMA |
FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIFLUCAN | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020090 | PFIZER |
| FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 079150 | AUROBINDO PHARMA |
| FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 215738 | ZHEJIANG POLY PHARM |