Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020688
Company: ALCON LABS INC
Company: ALCON LABS INC
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 |
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 |