Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050344
Company: ALCON
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STATROL | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 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 |
|---|---|---|---|---|---|---|---|
| 03/12/1974 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/28/1999 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/05/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 11/29/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/18/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/28/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 08/08/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 11/23/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/23/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/24/1992 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/22/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/13/1981 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/16/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/03/1989 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/1992 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/31/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |