Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081126
Company: TEVA PARENTERAL
Company: TEVA PARENTERAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXAMETHASONE SODIUM PHOSPHATE | 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 |
|---|---|---|---|---|---|---|---|
| 08/31/1990 | 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 |
|---|---|---|---|---|---|
| 08/31/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/07/2001 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 06/01/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/23/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 10/23/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |