Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007961
Company: APTALIS PHARMA US

Products on NDA 7961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENTYL	DICYCLOMINE HYDROCHLORIDE	10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SYRUP;ORAL	Discontinued	None	Yes	No

Labels for NDA 007961

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2011	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf
02/02/2007	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf