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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214770
Company: MSD MERCK CO

Products on NDA 214770

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214770

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

Labels for NDA 214770

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

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