Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 209620 ALEMBIC PHARMS LTD
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 207411 SOMERSET THERAPS LLC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078738 SUN PHARM

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English