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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077259
Company: FDC LTD

Products on ANDA 077259

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT1	No	No
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077259

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2008	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
03/25/2010	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 077259

TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074778	BAUSCH AND LOMB
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	077259	FDC LTD
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	078771	MANKIND PHARMA
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	217343	MICRO LABS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074746	PACIFIC PHARMA
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074261	SANDOZ
TIMOPTIC	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT1	018086	BAUSCH AND LOMB INC

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074776	BAUSCH AND LOMB
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	077259	FDC LTD
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	078771	MANKIND PHARMA
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	217343	MICRO LABS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074747	PACIFIC PHARMA
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074262	SANDOZ
TIMOPTIC	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT1	018086	BAUSCH AND LOMB INC

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