Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212291
Company: AKORN

Products on ANDA 212291

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 212291

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212291Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212291

TIMOLOL MALEATE

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	212291	AKORN
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	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