Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050023
Company: HARROW EYE
Company: HARROW EYE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/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 |
|---|---|---|---|---|---|---|---|
| 06/06/1963 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050023s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050023Orig1s037ltr.pdf | |
| 12/18/2017 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050023s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050023Orig1s036ltr.pdf | |
| 04/10/2017 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050023s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050023Orig1s032ltr.pdf | |
| 05/27/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/2008 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050023s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050023s025ltr.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. |
||
| 10/10/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/27/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/1995 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/03/1989 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1977 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1973 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1971 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1966 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050023s037lbl.pdf | |
| 12/18/2017 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050023s036lbl.pdf | |
| 04/10/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050023s032lbl.pdf | |
| 04/24/2008 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050023s025lbl.pdf |
MAXITROL
SUSPENSION/DROPS;OPHTHALMIC; 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXASPORIN | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AT | 064135 | BAUSCH AND LOMB |
| MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 050023 | HARROW EYE |
| MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AT | 062341 | SANDOZ |