Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020688
Company: ALCON LABS INC

Products on NDA 20688

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PATADAY TWICE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	Yes	Yes

Labels for NDA 020688

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2020	SUPPL-32	Efficacy-Rx To OTC Switch	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020688s032,021545s022lbl.pdf
04/17/2003	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20688slr016_patanol_lbl.pdf