Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010562
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDELTRA-TBA | PREDNISOLONE TEBUTATE | 20MG/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 |
|---|---|---|---|---|---|---|---|
| 07/25/1956 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/01/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1993 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 12/11/1989 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/16/1989 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/04/1982 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/04/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/15/1979 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 07/02/1980 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/08/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/08/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 08/08/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |