Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040266
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/26/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40266_Methotrexate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40266ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040266_methotrexate-preservative-free_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2023 | SUPPL-17 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/14/2021 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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09/14/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
03/03/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
09/28/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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01/24/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/26/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40266_Methotrexate_Prntlbl.pdf |
METHOTREXATE PRESERVATIVE FREE
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040266 | FRESENIUS KABI USA |