Drugs@FDA: FDA-Approved Drugs
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/27/1960 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
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, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011963s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011963Orig1s052ltr.pdf | |
07/03/2018 | SUPPL-48 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011963Orig1s048ltr.pdf |
02/28/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/09/2006 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011963s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011963s034ltr.pdf | |
04/12/2002 | SUPPL-32 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
03/10/1998 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/21/1995 | SUPPL-30 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/17/1993 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/13/1990 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/09/1990 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/01/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/29/1988 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/30/1984 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
05/11/1987 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
05/26/1982 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
06/10/1982 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/28/1981 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/25/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/19/1981 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/01/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
01/02/1980 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
08/09/1978 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
08/09/1978 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/09/1978 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/13/1976 | SUPPL-12 |
Label is not available on this site. |
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 |