Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| 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/GM;10,000 UNITS/GM | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 07/19/1963 | 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-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050065s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050065Orig1s065ltr.pdf | |
| 12/18/2017 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050065Orig1s064ltr.pdf | |
| 04/12/2017 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050065Orig1s061ltr.pdf | |
| 10/06/2015 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/2012 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/2012 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2004 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50065s043,044ltr.pdf | |
| 07/15/2004 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50065s043,044ltr.pdf | |
| 12/11/2002 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/2003 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50065slr040,scm039ltr.pdf | |
| 07/23/2003 | SUPPL-39 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50065slr040,scm039ltr.pdf | |
| 02/09/2001 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1999 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1996 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1995 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1982 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1978 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/20/1973 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1973 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1973 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/1972 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/12/1972 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1972 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/1972 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/09/1971 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/22/1971 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/04/1970 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1992 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1992 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/22/1988 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/30/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/30/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/23/1983 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1983 | 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 |
|---|---|---|---|---|---|
| 05/14/2021 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050065s065lbl.pdf | |
| 12/18/2017 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s064lbl.pdf | |
| 04/12/2017 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050065s061lbl.pdf | |
| 07/15/2004 | SUPPL-44 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf | |
| 07/15/2004 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50065s043,044lbl.pdf | |
| 07/23/2003 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf | |
| 07/23/2003 | SUPPL-39 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50065slr040,scm039_maxitrol_lbl.pdf |
MAXITROL
OINTMENT;OPHTHALMIC; 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | Yes | AT | 050065 | SANDOZ |
| NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | No | AT | 064063 | BAUSCH AND LOMB |
| NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | No | AT | 062938 | PADAGIS US |