Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016860
Company: NOVEN THERAP

Products on NDA 16860

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESKALITH	LITHIUM CARBONATE	300MG	CAPSULE;ORAL	Discontinued	None	No	No

Labels for NDA 016860

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2004	SUPPL-74	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf