Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201656
Company: ACERUS PHARMS

• Medication Guide

• Summary Review

Products on NDA 201656

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOCTIVA	DESMOPRESSIN ACETATE	0.00083MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	Yes	No
NOCTIVA	DESMOPRESSIN ACETATE	0.00166MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201656

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201656lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201656Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/201656Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/201656Orig1s000SumR.pdf

Labels for NDA 201656

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201656lbl.pdf