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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077354
Company: APOTEX INC

Products on ANDA 077354

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077354

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2006	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2007	SUPPL-5	Labeling		Label is not available on this site.

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

KETOTIFEN FUMARATE

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 0.025% BASE

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ALAWAY	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	021996	BAUSCH AND LOMB
ALAWAY	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	208158	BAUSCH AND LOMB INC
CHILDREN'S ALAWAY	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	021996	BAUSCH AND LOMB
KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	077354	APOTEX INC
KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	204059	BAYSHORE PHARMS LLC
KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	077958	SENTISS
ZADITOR	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	077200	ALCON PHARMS LTD

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