Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 200MG BASE/8ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/1986 | 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 |
|---|---|---|---|---|---|
| 10/25/2021 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2021 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2021 | SUPPL-34 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2013 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2011 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/19/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/24/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/17/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/22/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 01/28/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/11/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 08/11/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/12/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/03/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 04/25/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/20/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |