Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078621
Company: APOTEX INC

Products on ANDA 078621

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 078621

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2009	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078621

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