Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206276
Company: ALCON LABS INC
Company: ALCON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PATADAY ONCE DAILY RELIEF | OLOPATADINE HYDROCHLORIDE | EQ 0.7% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/30/2015 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206276s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206276Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206276Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/25/2021 | SUPPL-6 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206276Orig1s006lbl.pdf | |
07/13/2020 | SUPPL-5 | Efficacy-Rx To OTC Switch |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206276Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206276Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/206276Orig1s005.pdf | |
11/27/2015 | SUPPL-1 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206276Orig1s001.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/25/2021 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206276Orig1s006lbl.pdf | |
07/13/2020 | SUPPL-5 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206276Orig1s005lbl.pdf | |
01/30/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206276s000lbl.pdf |
PATADAY ONCE DAILY RELIEF
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION/DROPS;OPHTHALMIC; EQ 0.7% BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
PATADAY ONCE DAILY RELIEF | OLOPATADINE HYDROCHLORIDE | EQ 0.7% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 206276 | ALCON LABS INC |