Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212942
Company: ALEMBIC

Products on ANDA 212942

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212942

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212942Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212942

TIMOLOL MALEATE

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AB

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, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	212942	ALEMBIC
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	215733	DR REDDYS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	214645	GLAND
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	Yes	AB	020963	SANDOZ
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	210640	SOMERSET THERAPS LLC
TIMOPTIC-XE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	Yes	AB	020330	BAUSCH AND LOMB INC

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AB

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, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	212942	ALEMBIC
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	215733	DR REDDYS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	213540	EUGIA PHARMA
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	214645	GLAND
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	Yes	AB	020963	SANDOZ
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	No	AB	210640	SOMERSET THERAPS LLC
TIMOPTIC-XE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	Prescription	Yes	AB	020330	BAUSCH AND LOMB INC