Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011210
Company: PFIZER

Products on NDA 11210

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESSALON	BENZONATATE	100MG	CAPSULE;ORAL	Prescription	AA	Yes	No
TESSALON	BENZONATATE	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Labels for NDA 011210

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/20/2011	SUPPL-53	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf