Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050456
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/ML;16,250 UNITS/ML | SOLUTION/DROPS;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 |
|---|---|---|---|---|---|
| 09/09/1997 | SUPPL-20 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-456S020.pdf |
| 11/01/1995 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/03/1989 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 05/15/1987 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 05/15/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/08/1984 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 07/28/1983 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 01/11/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/13/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/21/1978 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/09/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/09/1978 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 03/01/1977 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/03/1976 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 03/01/1976 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/28/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/31/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |