Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213514
Company: GLAND

Products on ANDA 213514

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.7% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213514

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213514Orig1s000TAltr.pdf

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

OLOPATADINE HYDROCHLORIDE

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 0.7% BASE

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.7% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	213514	GLAND
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	EQ 0.7% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	206276	ALCON LABS INC