Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080020
Company: ALCON
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOPTO CETAMIDE | SULFACETAMIDE SODIUM | 15% | 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 |
|---|---|---|---|---|---|---|---|
| 05/05/1971 | 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 |
|---|---|---|---|---|---|
| 12/23/2002 | SUPPL-31 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-30 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 04/28/2000 | SUPPL-29 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/04/1999 | SUPPL-26 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/03/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/03/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 06/04/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 06/04/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/15/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |