Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011963
Company: FERA PHARMS LLC
Company: FERA PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | 0.125% | FOR SOLUTION;OPHTHALMIC | Prescription | None | Yes | Yes |
| PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | 0.03% | FOR SOLUTION;OPHTHALMIC | Discontinued | None | No | No |
| PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | 0.25% | FOR SOLUTION;OPHTHALMIC | Discontinued | None | No | No |
| PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | 0.06% | FOR SOLUTION;OPHTHALMIC | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/28/2021 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011963s052lbl.pdf | |
| 10/28/2021 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011963s052lbl.pdf | |
| 03/09/2006 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011963s034lbl.pdf |