Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 205438
Company: HI TECH
Company: HI TECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIFLURIDINE | TRIFLURIDINE | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TRIFLURIDINE
SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRIFLURIDINE | TRIFLURIDINE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 205438 | HI TECH |
| TRIFLURIDINE | TRIFLURIDINE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 074311 | SANDOZ INC |
| VIROPTIC | TRIFLURIDINE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 018299 | MONARCH PHARMS |
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