Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019116
Company: BAUSCH

Products on NDA 19116

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOCOID	HYDROCORTISONE BUTYRATE	0.1%	SOLUTION;TOPICAL	Prescription	AT	Yes	Yes

Labels for NDA 019116

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2014	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019116s009lbl.pdf