Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010210
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METIMYD | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | 0.5%;10% | SUSPENSION/DROPS;OPHTHALMIC | Discontinued | None | No | No |
| METIMYD | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | 0.5%;10% | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/1965 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/01/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1997 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/26/1997 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/13/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/06/1989 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/03/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/12/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1987 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/20/1986 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/28/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/28/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/11/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 09/09/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/23/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/23/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/23/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |