Drugs@FDA: FDA-Approved Drugs
Company: ALCON PHARMS LTD
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/ML;10,000 UNITS/ML | SUSPENSION/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 |
---|---|---|---|---|---|---|---|
11/17/1986 | 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 |
---|---|---|---|---|---|
06/16/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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02/19/1999 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/07/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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02/02/1999 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/07/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/16/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/30/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
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10/14/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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10/31/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |