Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 0.1% PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC, OTIC | 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 |
---|---|---|---|---|---|---|---|
01/16/1985 | 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 |
---|---|---|---|---|---|
03/06/2009 | SUPPL-24 | Labeling |
Label is not available on this site. |
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04/11/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
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05/10/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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02/19/1999 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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02/02/1999 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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07/29/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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12/04/1996 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/15/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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04/16/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
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02/08/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/08/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
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09/19/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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08/03/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/03/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/14/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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05/02/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |