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 | Discontinued | None | 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. |
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| 07/18/2002 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 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. |
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| 10/27/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/27/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |