Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086906
Company: ELKINS SINN
Company: ELKINS SINN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 40MG BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/15/1980 | 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 |
|---|---|---|---|---|---|
| 10/04/1988 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 07/15/1988 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 03/10/1988 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/10/1988 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1987 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/14/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1986 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/05/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/21/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/21/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/10/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |