Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088771
Company: CAPLIN
Company: CAPLIN
| 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 |
|---|---|---|---|---|---|
| 09/19/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 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. |
||
| 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. |
||
| 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. |
||
| 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. |