Details for New Drug Application (NDA): 020688

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NDA 020688 describes PATADAY TWICE DAILY RELIEF, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PATADAY TWICE DAILY RELIEF profile page.

The generic ingredient in PATADAY TWICE DAILY RELIEF is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for 020688

Tradename:	PATADAY TWICE DAILY RELIEF
Applicant:	Alcon Labs Inc
Ingredient:	olopatadine hydrochloride
Patents:	0

Pharmacology for NDA: 020688

Mechanism of Action	Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for 020688

Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Histamine H1 Antagonists, Non-Sedating

Suppliers and Packaging for NDA: 020688

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688	NDA	Alcon Laboratories, Inc.	0065-4274	0065-4274-01	1 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01) / 5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.1% BASE
Approval Date:	Dec 18, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020688

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,871,865	⤷ Get Started Free
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	5,641,805*PED	⤷ Get Started Free
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	5,116,863*PED	⤷ Get Started Free
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,923,892	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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