Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017011
Company: ABBVIE

Products on NDA 17011

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRED FORTE	PREDNISOLONE ACETATE	1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	AB	Yes	Yes

Labels for NDA 017011

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2018	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017011s050lbl.pdf
05/04/2017	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017011s047lbl.pdf