Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090919
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPINASTINE HYDROCHLORIDE | EPINASTINE 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 |
---|---|---|---|---|---|---|---|
10/31/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/06/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
EPINASTINE 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 |
---|---|---|---|---|---|---|---|---|
EPINASTINE HYDROCHLORIDE | EPINASTINE HYDROCHLORIDE | 0.05% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090919 | APOTEX |
EPINASTINE HYDROCHLORIDE | EPINASTINE HYDROCHLORIDE | 0.05% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090870 | BRECKENRIDGE |
EPINASTINE HYDROCHLORIDE | EPINASTINE HYDROCHLORIDE | 0.05% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090951 | SOMERSET THERAPS LLC |