Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040314
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TROPICACYL | TROPICAMIDE | 0.5% | 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 |
---|---|---|---|---|---|---|---|
09/29/2000 | 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 |
---|---|---|---|---|---|
07/25/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
06/29/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
TROPICACYL
SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MYDRIACYL | TROPICAMIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 084305 | SANDOZ |
TROPICACYL | TROPICAMIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040314 | EPIC PHARMA LLC |
TROPICAMIDE | TROPICAMIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040067 | BAUSCH AND LOMB |