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 OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
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
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

SOLUTION/DROPS;OPHTHALMIC; EQ 0.2% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204723 AKORN
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209420 ALEMBIC PHARMS LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090918 APOTEX INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209995 AUROBINDO PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090848 BARR LABS INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206087 CIPLA
PATADAY OLOPATADINE HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021545 NOVARTIS

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