Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088810
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE INTENSOL | PREDNISONE | 5MG/ML | SOLUTION;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/20/1985 | 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 |
|---|---|---|---|---|---|
| 12/02/2020 | SUPPL-29 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/04/2001 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/11/2001 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 02/22/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 10/07/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 03/30/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 10/29/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/10/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/05/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/13/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 09/11/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/29/1988 | SUPPL-1 | Bioequivalence |
Label is not available on this site. |