Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086358
Company: BRISTOL
Company: BRISTOL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEXATE | METHOTREXATE SODIUM | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MEXATE | METHOTREXATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MEXATE | METHOTREXATE SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MEXATE | METHOTREXATE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/05/1979 | 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 |
|---|---|---|---|---|---|
| 07/12/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 04/13/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1987 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/02/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |