Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021795
Company: FERRING

• Other Important Information from FDA

• Summary Review

Products on NDA 021795

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET;ORAL	Discontinued	None	No	No
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	UNKNOWN	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021795s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021795_desmopressin_acetate.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021795s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021795s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021795Orig1s006ltr.pdf
04/20/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/28/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021795

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021795s006lbl.pdf