Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022517
Company: FERRING PHARMS INC

• Medication Guide

Products on NDA 022517

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOCDURNA	DESMOPRESSIN ACETATE	0.0277MG	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
NOCDURNA	DESMOPRESSIN ACETATE	0.0553MG	TABLET;SUBLINGUAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022517

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022517s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022517Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/022517Orig1s000TOC.html

Labels for NDA 022517

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022517s000lbl.pdf