Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020803
Company: BAUSCH AND LOMB

Products on NDA 20803

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALREX	LOTEPREDNOL ETABONATE	0.2%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Labels for NDA 020803

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20803lbl.pdf