Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087440
Company: LUITPOLD
Company: LUITPOLD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/21/1982 | 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 |
|---|---|---|---|---|---|
| 07/03/2014 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/31/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/07/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/17/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/16/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 02/28/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/11/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/27/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 10/02/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/16/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/16/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/08/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |