Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062166
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE | BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/14/1981 | 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 |
|---|---|---|---|---|---|
| 09/12/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/07/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/27/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/27/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/14/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/09/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/17/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |