Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019806
Company: ENDO OPERATIONS

Products on NDA 19806

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEMPREX-D	ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE	8MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Labels for NDA 019806

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019806s013lbl.pdf