Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017922
Company: FERRING PHARMS INC

• Other Important Information from FDA

Products on NDA 17922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DDAVP	DESMOPRESSIN ACETATE	0.01%	SOLUTION;NASAL	Discontinued	None	Yes	No
DDAVP	DESMOPRESSIN ACETATE	0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SPRAY, METERED;NASAL	Discontinued	None	Yes	No
DDAVP (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	Yes	No

Labels for NDA 017922

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2018	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017922s046lbl.pdf
11/05/2015	SUPPL-42	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf
11/05/2015	SUPPL-42	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf
11/05/2015	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf
10/26/2007	SUPPL-38	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf
11/10/2005	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf