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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217770
Company: SOMERSET THERAPS LLC

Products on ANDA 217770

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEPOTASTINE BESILATE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217770

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217770

BEPOTASTINE BESILATE

SOLUTION/DROPS;OPHTHALMIC; 1.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BEPOTASTINE BESILATE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	214588	ALEMBIC
BEPOTASTINE BESILATE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	206220	MYLAN
BEPOTASTINE BESILATE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	217770	SOMERSET THERAPS LLC
BEPREVE	BEPOTASTINE BESILATE	1.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	022288	BAUSCH AND LOMB INC

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