Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020065
Company: BAUSCH AND LOMB

Products on NDA 20065

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPCON-A	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	Yes	Yes

Labels for NDA 020065

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2022	SUPPL-33	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020065Orig1s033lbl.pdf
07/31/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020065s017lbl.pdf