Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207411
Company: SOMERSET THERAPS LLC

Products on ANDA 207411

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2021	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.
04/30/2021	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207411

AZELASTINE 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
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	209620	ALEMBIC
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078621	APOTEX INC
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	210092	GLAND PHARMA LTD
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202305	SANDOZ
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	207411	SOMERSET THERAPS LLC
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078738	SUN PHARM