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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/18/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020688Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2020 | SUPPL-33 | 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-32 | 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/2020/020688Orig1s032.pdf | |
| 06/30/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2003 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20688slr016_patanol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20688slr016ltr.pdf | |
| 03/13/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/2001 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020688_S013_PATANOL.pdf |
| 03/20/2000 | SUPPL-12 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20688S12LTR.PDF |
| 02/18/2000 | SUPPL-11 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020688_S011_PATANOL.pdf |
| 08/17/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S010_PATANOL.pdf |
| 09/28/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S009_PATANOL.pdf |
| 02/16/1999 | SUPPL-8 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S008_PATANOL.pdf |
| 02/05/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-6 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S006_PATANOL.pdf |
| 10/14/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/19/1999 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S004_PATANOL.pdf |
| 05/29/1998 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S003_PATANOL.pdf |
| 09/04/1998 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S002_PATANOL.pdf |
| 01/15/1998 | SUPPL-1 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S001_PATANOL.pdf |
| 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 |
PATADAY TWICE 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 0.1% BASE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 209919 | ALEMBIC |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 078350 | APOTEX |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 204812 | EUGIA PHARMA |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 209619 | GLAND PHARMA LTD |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 206306 | SOMERSET THERAPS LLC |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 203152 | USV |
| PATADAY TWICE DAILY RELIEF | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | Yes | 020688 | ALCON LABS INC |