Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015230
Company: HIKMA

Products on NDA 15230

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMICAR	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	AA	Yes	No

Labels for NDA 015230

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2009	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf
08/19/2008	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf