Drugs@FDA: FDA-Approved Drugs
Company: HARROW EYE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MAXIDEX | DEXAMETHASONE | 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 |
---|---|---|---|---|---|---|---|
06/20/1962 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
12/10/2021 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013422s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/013422Orig1s049ltr.pdf | |
05/14/2021 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013422s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/013422Orig1s046ltr.pdf | |
11/03/2017 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013422s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013422Orig1s045ltr.pdf | |
08/05/2016 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/10/2016 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/07/2015 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/17/2003 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13422slr035_maxidex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13422slr035ltr.pdf | |
12/11/2002 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/04/2002 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/04/2000 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/17/1999 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/07/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/05/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/1999 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/04/1998 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/17/1996 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/26/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
03/18/1996 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/01/1995 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/01/1995 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/14/1995 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/28/1989 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/06/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/02/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/21/1984 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/05/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/08/1984 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/05/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/06/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/06/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
05/31/1990 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/10/2021 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013422s049lbl.pdf | |
05/14/2021 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013422s046lbl.pdf | |
11/03/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013422s045lbl.pdf | |
04/17/2003 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13422slr035_maxidex_lbl.pdf |