Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201529
Company: EUGIA PHARMA SPECLTS
Company: EUGIA PHARMA SPECLTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 200MG BASE/8ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 250MG BASE/10ML (EQ 25MG BASE/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 |
---|---|---|---|---|---|---|---|
03/29/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/19/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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07/19/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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10/05/2015 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/05/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |