Application 011719
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | No | No |
| 003 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL | No | No |
| 004 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 2.5MG BASE/ML | No | No |
| 005 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 25MG BASE/ML | No | No |
| 006 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL | No | No |
| 007 | METHOTREXATE LPF | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 25MG BASE/ML | No | No |
| 009 | METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 010 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | Yes | Yes |
| 011 | METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) | No | No |
| 012 | METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | Yes | Yes |
| 013 | METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 014 | METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61703-124 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-350 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | METHOTREXATE | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | METHOTREXATE | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
| 61703-408 | Methotrexate | Methotrexate | Hospira, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82358 | SUPPL | 2025-05-30 |
| 82341 | SUPPL | 2025-05-29 |
| 79105 | SUPPL | 2024-07-16 |
| 79104 | SUPPL | 2024-07-16 |
| 76613 | SUPPL | 2024-07-16 |
| 76607 | SUPPL | 2023-11-17 |
| 70917 | SUPPL | 2022-05-03 |
| 70913 | SUPPL | 2022-05-03 |
| 66922 | SUPPL | 2021-03-30 |
| 66921 | SUPPL | 2021-03-30 |
| 54048 | SUPPL | 2018-05-08 |
| 54036 | SUPPL | 2018-05-07 |
| 53060 | SUPPL | 2018-03-20 |
| 53041 | SUPPL | 2018-03-16 |
| 10775 | SUPPL | 2015-11-25 |
| 11956 | SUPPL | 2015-11-23 |
| 33054 | SUPPL | 2011-11-04 |
| 11955 | SUPPL | 2011-11-03 |
| 11954 | SUPPL | 2005-04-19 |
| 11953 | SUPPL | 2004-12-30 |
| 10774 | SUPPL | 2004-02-03 |
| 11952 | SUPPL | 2004-02-02 |
| 11951 | SUPPL | 2003-08-06 |
| 283 | SUPPL | 2003-01-03 |
| 11950 | SUPPL | 2002-02-20 |
| 282 | SUPPL | 2002-02-20 |