Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087547
Company: ALCON
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOPTO CETAPRED | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | 0.25%;10% | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 07/21/1981 | 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 |
|---|---|---|---|---|---|
| 04/28/2000 | SUPPL-22 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/21/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/07/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/05/1995 | SUPPL-16 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 08/04/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/28/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/13/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/28/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 06/04/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/05/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/04/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/27/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/26/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/27/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/10/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |