Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011719
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHOTREXATE LPF | METHOTREXATE SODIUM | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/10/1959 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-138 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011719s138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011719Orig1s138ltr.pdf | |
| 05/02/2022 | SUPPL-135 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011719Orig1s135lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/011719Orig1s135ltr.pdf | |
| 03/29/2021 | SUPPL-131 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011719Orig1s131lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011719Orig1s131ltr.pdf | |
| 03/15/2018 | SUPPL-126 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s126lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011719Orig1s126ltr.pdf | |
| 05/07/2018 | SUPPL-125 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011719Orig1s125ltr.pdf | |
| 02/03/2016 | SUPPL-124 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/2015 | SUPPL-122 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011719Orig1s122ltr.pdf | |
| 08/14/2015 | SUPPL-121 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/2011 | SUPPL-117 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011719s117ltr.pdf | |
| 04/13/2005 | SUPPL-108 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011719s108ltr.pdf |
| 12/15/2004 | SUPPL-107 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719s107ltr.pdf |
| 01/27/2004 | SUPPL-106 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719slr106ltr.pdf | |
| 07/29/2003 | SUPPL-105 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr105ltr.pdf |
| 01/03/2003 | SUPPL-104 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr104ltr.pdf |
| 02/20/2002 | SUPPL-103 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf |
| 02/20/2002 | SUPPL-102 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf |
| 05/08/2001 | SUPPL-100 | Labeling |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-99 | Labeling |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-98 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/22/1998 | SUPPL-97 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/2000 | SUPPL-96 | Labeling |
Label is not available on this site. |
||
| 05/20/1997 | SUPPL-95 | Labeling |
Label is not available on this site. |
||
| 04/25/1995 | SUPPL-94 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1992 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1991 | SUPPL-86 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/24/1990 | SUPPL-85 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/1991 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1989 | SUPPL-81 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1988 | SUPPL-79 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/07/1988 | SUPPL-78 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1988 | SUPPL-77 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/18/1990 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 12/08/1986 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1987 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1986 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 09/16/1986 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1987 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1983 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1982 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 04/08/1983 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1982 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1982 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 12/07/1981 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1981 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1980 | SUPPL-53 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/29/1980 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1979 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1980 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1978 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1978 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/02/1979 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1978 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/14/1977 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1977 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1977 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1977 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1976 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1976 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1976 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1976 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1976 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1976 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1976 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1976 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/29/1976 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1975 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/03/1975 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/03/1975 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/22/1975 | SUPPL-21 | 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 |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-138 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011719s138lbl.pdf | |
| 05/02/2022 | SUPPL-135 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011719Orig1s135lbl.pdf | |
| 03/29/2021 | SUPPL-131 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011719Orig1s131lbl.pdf | |
| 05/07/2018 | SUPPL-125 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s125lbl.pdf | |
| 03/15/2018 | SUPPL-126 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011719s126lbl.pdf | |
| 11/20/2015 | SUPPL-122 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf | |
| 11/20/2015 | SUPPL-122 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf | |
| 11/01/2011 | SUPPL-117 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf | |
| 01/27/2004 | SUPPL-106 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_lbl.pdf |
METHOTREXATE LPF
There are no Therapeutic Equivalents.
METHOTREXATE PRESERVATIVE FREE
There are no Therapeutic Equivalents.
METHOTREXATE SODIUM
INJECTABLE;INJECTION; EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040263 | FRESENIUS KABI USA |
| METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 011719 | HOSPIRA |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040767 | ACCORD HLTHCARE |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 089340 | HIKMA |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040843 | PHARMACHEMIE BV |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203407 | SAGENT PHARMS INC |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090039 | SANDOZ |
METHOTREXATE SODIUM PRESERVATIVE FREE
INJECTABLE;INJECTION; EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040716 | ACCORD HLTHCARE |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 011719 | HOSPIRA |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 040843 | PHARMACHEMIE BV |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203407 | SAGENT PHARMS INC |
| METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090029 | SANDOZ |