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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021545
Company: ALCON LABS INC

Products on NDA 021545

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021545

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.

Labels for NDA 021545

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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

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