Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022036
Company: CURRAX

• Summary Review

Products on NDA 22036

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SILENOR	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
SILENOR	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 022036

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf
03/17/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022036lbl.pdf