Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214770
Company: MSD MERCK CO
Company: MSD MERCK CO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NOXAFIL POWDERMIX KIT | POSACONAZOLE | 300MG | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
05/31/2021 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214770Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214770Orig1s000; 205053Orig1s012; 205596Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214770Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/13/2022 | SUPPL-2 | 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-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214770Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214770Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/20/2022 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214770Orig1s001lbl.pdf | |
01/13/2022 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003s028,205053s014,205596s015,214770s002lbl.pdf | |
05/31/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214770Orig1s000Lbl.pdf |