Details for New Drug Application (NDA): 021996

NDA 021996 describes CHILDREN'S ALAWAY, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from thirteen suppliers. Additional details are available on the CHILDREN'S ALAWAY profile page.

The generic ingredient in CHILDREN'S ALAWAY is ketotifen fumarate. There are five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.

Summary for 021996

Tradename:	CHILDREN'S ALAWAY
Applicant:	Bausch And Lomb
Ingredient:	ketotifen fumarate
Patents:	0

Pharmacology for NDA: 021996

Mechanism of Action

Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 021996

Anti-Allergic Agents

Antipruritics

Histamine H1 Antagonists

Suppliers and Packaging for NDA: 021996

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Walgreen Company	0363-0038	0363-0038-05	1 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLE
ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021996	NDA	Walgreen Company	0363-0038	0363-0038-10	1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.025% BASE
Approval Date:	Dec 1, 2006	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.025% BASE
Approval Date:	Feb 11, 2015	TE:		RLD:	Yes

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