Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062714
Company: ALCON PHARMS LTD
Company: ALCON PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE | EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 07/21/1986 | 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 |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 06/03/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1996 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 04/16/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/09/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/22/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |