Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090951
Company: SOMERSET THERAPS LLC

Products on ANDA 090951

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090951

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2011	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
08/18/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090951

EPINASTINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; 0.05%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	090919	APOTEX
EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	090870	BRECKENRIDGE
EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	090951	SOMERSET THERAPS LLC