Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016832
Company: ABBOTT

• Other Important Information from FDA

Products on NDA 16832

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYLERT	PEMOLINE	18.75MG	TABLET;ORAL	Discontinued	None	No	No
CYLERT	PEMOLINE	37.5MG	TABLET;ORAL	Discontinued	None	No	No
CYLERT	PEMOLINE	75MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 016832

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2003	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf