Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062938
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 | AT | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/31/1989 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/10/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
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 |