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New Drug Application (NDA): 205596
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOXAFIL POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
03/13/2014 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205596s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205596Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205596Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205596Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/13/2022 SUPPL-15 Labeling-Package Insert, Labeling-Patient 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-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205596Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205596Orig1s014ltr.pdf
06/17/2021 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205596s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205053Orig1s011; 205596Orig1s013ltr.pdf
05/31/2021 SUPPL-12 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214770Orig1s000,205053Orig1s012,205596Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214770Orig1s000;%20205053Orig1s012;%20205596Orig1s012ltr.pdf
09/16/2020 SUPPL-10 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-8 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-7 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-5 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-4 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-3 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
11/13/2015 SUPPL-1 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/20/2022 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205596Orig1s014lbl.pdf
01/13/2022 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003s028,205053s014,205596s015,214770s002lbl.pdf
01/13/2022 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003s028,205053s014,205596s015,214770s002lbl.pdf
06/17/2021 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205596s013lbl.pdf
05/31/2021 SUPPL-12 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214770Orig1s000,205053Orig1s012,205596Orig1s012lbl.pdf
09/16/2020 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010lbl.pdf
09/16/2020 SUPPL-10 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010lbl.pdf
03/11/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s024,205053s008,205596s007lbl.pdf
02/21/2019 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s025,205053s009,205596s008lbl.pdf
01/04/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022003s022,205053s006,205596s005lbl.pdf
09/09/2016 SUPPL-4 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-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
11/13/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
11/13/2015 SUPPL-3 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
11/13/2015 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
03/13/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205596s000lbl.pdf

NOXAFIL

SOLUTION;INTRAVENOUS; 300MG/16.7ML (18MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NOXAFIL POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 205596 MERCK SHARP DOHME
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208768 ENDO OPERATIONS
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214842 EUGIA PHARMA
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209983 FRESENIUS KABI USA
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 217553 GLAND PHARMA LTD
POSACONAZOLE POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 211500 MYLAN LABS LTD
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