Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083342
Company: ALCON
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAXIDEX | DEXAMETHASONE SODIUM PHOSPHATE | EQ 0.05% PHOSPHATE | 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 |
|---|---|---|---|---|---|---|---|
| 10/23/1973 | 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 |
|---|---|---|---|---|---|
| 03/23/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/05/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/12/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/19/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |