U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209620
Company: ALEMBIC PHARMS LTD
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
03/20/2019 ORIG-1 Approval STANDARD

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 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 210092 GLAND PHARMA LTD
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
Back to Top