Details for New Drug Application (NDA): 021545

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NDA 021545 describes PATADAY ONCE DAILY RELIEF, which is a drug marketed by Alcon Labs Inc and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PATADAY ONCE DAILY RELIEF profile page.

The generic ingredient in PATADAY ONCE 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 021545

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

Pharmacology for NDA: 021545

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

Medical Subject Heading (MeSH) Categories for 021545

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

Suppliers and Packaging for NDA: 021545

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545	NDA	Alcon Laboratories, Inc.	0065-8150	0065-8150-01	1 BOTTLE, PLASTIC in 1 CARTON (0065-8150-01) / 2.5 mL in 1 BOTTLE, PLASTIC
PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545	NDA	Alcon Laboratories, Inc.	0065-8150	0065-8150-03	2 BOTTLE, PLASTIC in 1 CARTON (0065-8150-03) / 2.5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.2% BASE
Approval Date:	Dec 22, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021545

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	5,116,863*PED	⤷ Get Started Free
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	7,402,609*PED	⤷ Get Started Free
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	6,995,186*PED	⤷ Get Started Free
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	5,641,805*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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