Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040054
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE | TABLET;ORAL | Prescription | AB | No | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/29/2020 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf | |
| 10/29/2020 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf | |
| 10/29/2020 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf | |
| 10/29/2020 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040054s015,s016,s017.pdf |