Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020258
Company: HARROW EYE
Company: HARROW EYE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IOPIDINE | APRACLONIDINE HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/1993 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2026 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020258s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020258Orig1s034ltr.pdf | |
| 03/01/2018 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020258s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020258 Orig1s030ltr.pdf | |
| 04/06/2017 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020258s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020258Orig1s026ltr.pdf | |
| 05/09/2003 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20258slr019_iopidine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20258slr019ltr.pdf | |
| 12/04/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/28/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1997 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/17/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/18/2026 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020258s034lbl.pdf | |
| 03/01/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020258s030lbl.pdf | |
| 04/06/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020258s026lbl.pdf | |
| 05/09/2003 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20258slr019_iopidine_lbl.pdf |
IOPIDINE
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APRACLONIDINE HYDROCHLORIDE | APRACLONIDINE HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 077764 | RISING |
| IOPIDINE | APRACLONIDINE HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 020258 | HARROW EYE |