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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216533
Company: INGENUS PHARMS LLC

Products on ANDA 216533

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	AT3	No	No
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT3	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216533

TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT3

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	AT3	212592	AMRING PHARMS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT3	216533	INGENUS PHARMS LLC
TIMOPTIC IN OCUDOSE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT3	019463	BAUSCH AND LOMB INC

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT3

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	AT3	212592	AMRING PHARMS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT3	212291	EPIC PHARMA LLC
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT3	216533	INGENUS PHARMS LLC
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT3	216596	MICRO LABS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT3	217195	SENTISS PHARMA
TIMOPTIC IN OCUDOSE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT3	019463	BAUSCH AND LOMB INC

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