Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062874
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;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 |
|---|---|---|---|---|---|---|---|
| 05/11/1988 | 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 |
|---|---|---|---|---|---|
| 05/25/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 10/21/2004 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 02/04/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 02/19/1999 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 12/15/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/16/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/16/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/21/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/06/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |