Drugs@FDA: FDA Approved Drug Products

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

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 203660 AKORN
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 202305 SANDOZ INC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078738 SUN PHARMA GLOBAL
OPTIVAR AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021127 MYLAN SPECIALITY LP

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