Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021545
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 0.2% 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 |
---|---|---|---|---|---|---|---|
12/22/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021545lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021545ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021545s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/13/2021 | SUPPL-24 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021545Orig1s024lbl.pdf | |
09/30/2020 | SUPPL-23 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020688Orig1s033, 021545Orig1s023ltr.pdf |
02/14/2020 | SUPPL-22 | Efficacy-Rx To OTC Switch |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020688s032,021545s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020688s032, 021545s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021545Orig1s022.pdf | |
10/08/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/08/2010 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021545s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021545s013ltr.pdf | |
06/08/2007 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s008, 021545s009ltr.pdf | |
06/08/2007 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s008, 021545s009ltr.pdf | |
04/26/2007 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021545s006ltr.pdf | |
10/04/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/13/2021 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021545Orig1s024lbl.pdf | |
02/14/2020 | SUPPL-22 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020688s032,021545s022lbl.pdf | |
12/08/2010 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021545s013lbl.pdf | |
06/08/2007 | SUPPL-9 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s008s009lbl.pdf | |
06/08/2007 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s008s009lbl.pdf | |
04/26/2007 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021545s006lbl.pdf | |
12/22/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021545lbl.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 0.2% BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 209420 | ALEMBIC |
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 090918 | APOTEX |
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 090848 | BARR LABS INC |
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 209995 | EUGIA PHARMA |
OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 209752 | GLAND PHARMA LTD |
PATADAY ONCE DAILY RELIEF | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 021545 | ALCON LABS INC |