Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021545
Company: NOVARTIS
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
02/14/2020 SUPPL-22 Efficacy-Rx To OTC Switch Label (PDF)
Letter (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
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
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 209752 GLAND PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 204620 MICRO LABS LTD INDIA
PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 021545 NOVARTIS

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