Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207524
Company: SOMERSET THERAPS LLC
Company: SOMERSET THERAPS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TROPICAMIDE | TROPICAMIDE | 1% | 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 |
---|---|---|---|---|---|---|---|
12/12/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TROPICAMIDE
SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MYDRIACYL | TROPICAMIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 084306 | ALCON LABS INC |
TROPICACYL | TROPICAMIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040315 | RISING PHARMA |
TROPICAMIDE | TROPICAMIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040064 | BAUSCH AND LOMB |
TROPICAMIDE | TROPICAMIDE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 207524 | SOMERSET THERAPS LLC |