Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078621
Company: APOTEX INC
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 | 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 |