Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022003
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOXAFIL | POSACONAZOLE | 40MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/15/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022003s000_NoxafilTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/03/2022 | SUPPL-30 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022003Orig1s030ltr.pdf | |
| 01/13/2022 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003s028,205053s014,205596s015,214770s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022003Orig1s028, 205053Orig1s014, 205596Orig1s015, 214770Orig1s002ltr.pdf | |
| 01/20/2022 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022003Orig1s027ltr.pdf | |
| 09/16/2020 | SUPPL-26 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010ltr.pdf | |
| 02/21/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s025,205053s009,205596s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022003Orig1s025,205053Orig1s009,205596Orig1s008ltr.pdf | |
| 03/11/2019 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s024,205053s008,205596s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022003Orig1s024, 205053Orig1s008, 205596Orig1s007ltr.pdf | |
| 01/04/2018 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022003s022,205053s006,205596s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022003Orig1s022,205053Orig1s006,205596Orig1s005ltr.pdf | |
| 09/09/2016 | SUPPL-21 | 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/2016/022003s021,205053s005,205596s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf |
| 11/13/2015 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf | |
| 04/11/2016 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf | |
| 08/13/2015 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/2015 | SUPPL-16 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s016ltr.pdf | |
| 06/15/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/2012 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf | |
| 06/21/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022003Orig1s011,s012,022027Orig1s002,s003ltr.pdf | |
| 09/08/2010 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022003s008,022027s001ltr.pdf | |
| 02/19/2009 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022003s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022003s007ltr.pdf | |
| 05/20/2008 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022003s002s006ltr.pdf |
| 05/20/2008 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022003s002s006ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/20/2022 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003Orig1s027lbl.pdf | |
| 01/13/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003s028,205053s014,205596s015,214770s002lbl.pdf | |
| 01/03/2022 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003Orig1s030lbl.pdf | |
| 09/16/2020 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010lbl.pdf | |
| 09/16/2020 | SUPPL-26 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010lbl.pdf | |
| 03/11/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s024,205053s008,205596s007lbl.pdf | |
| 02/21/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s025,205053s009,205596s008lbl.pdf | |
| 01/04/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022003s022,205053s006,205596s005lbl.pdf | |
| 09/09/2016 | SUPPL-21 | 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/2016/022003s021,205053s005,205596s004lbl.pdf |
| 11/13/2015 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf | |
| 11/13/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf | |
| 11/13/2015 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf | |
| 11/13/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf | |
| 07/14/2015 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003Orig1s016lbl.pdf | |
| 06/21/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf | |
| 06/21/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022003s011s012,022027s002s003lbl.pdf | |
| 09/08/2010 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022003s008,022027s001lbl.pdf | |
| 02/19/2009 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022003s007lbl.pdf | |
| 09/15/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022003lbl.pdf |
NOXAFIL
SUSPENSION;ORAL; 40MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NOXAFIL | POSACONAZOLE | 40MG/ML | SUSPENSION;ORAL | Prescription | Yes | AB | 022003 | SCHERING |
| POSACONAZOLE | POSACONAZOLE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 208773 | HIKMA |