Drugs@FDA: FDA-Approved Drugs
Company: HARROW EYE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLAREX | FLUOROMETHOLONE ACETATE | 0.1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/11/1986 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
---|---|---|---|---|---|
05/24/2024 | SUPPL-38 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019079Orig1s038ltr.pdf |
08/02/2022 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019079s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019079Orig1s033ltr.pdf | |
10/24/2016 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019079s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019079Orig1s030ltr.pdf | |
11/08/2006 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019079s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019079s024LTR.pdf | |
12/11/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/04/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/10/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/16/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/18/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/05/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/17/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/05/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/1999 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/04/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/04/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/30/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/21/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/26/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
07/19/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/18/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/01/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/01/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/13/1995 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/04/1987 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/09/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
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03/24/1986 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/02/2022 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019079s033lbl.pdf | |
10/24/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019079s030lbl.pdf | |
11/08/2006 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019079s024lbl.pdf |