Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088469
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 01/25/1984 | 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 |
|---|---|---|---|---|---|
| 02/08/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/02/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/03/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/16/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/18/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/10/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |