Application 086358
- Type
- ANDA
- Sponsor
- BRISTOL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEXATE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | No | No |
| 002 | MEXATE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL | No | No |
| 003 | MEXATE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL | No | No |
| 004 | MEXATE | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A086358-001 | MEXATE | METHOTREXATE SODIUM | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| A086358-002 | MEXATE | METHOTREXATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| A086358-003 | MEXATE | METHOTREXATE SODIUM | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| A086358-004 | MEXATE | METHOTREXATE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A086358-001 | MEXATE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A086358-002 | MEXATE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A086358-003 | MEXATE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A086358-004 | MEXATE | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A086358-001 | MEXATE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A086358-002 | MEXATE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A086358-003 | MEXATE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A086358-004 | MEXATE | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A086358-001 | MEXATE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A086358-002 | MEXATE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A086358-003 | MEXATE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A086358-004 | MEXATE | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A086358-001 | MEXATE | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A086358-002 | MEXATE | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A086358-003 | MEXATE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A086358-004 | MEXATE | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methotrexate Sodium | METHOTREXATE SODIUM | Elite Laboratories, Inc. | 89c05ea3-3be1-46dd-b112-29c436fd7289 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE SODIUM |
| Methotrexate | METHOTREXATE SODIUM | Sun Pharmaceutical Industries, Inc. | 8f1260de-b60c-4f0e-8af6-0e957b0a281b | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE SODIUM |
| Methotrexate Sodium | METHOTREXATE SODIUM | Hikma Pharmaceuticals USA Inc. | d71b1856-99d8-4a9e-9189-f87b6675f80a | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE SODIUM |
| Methotrexate | METHOTREXATE SODIUM | Fresenius Kabi USA, LLC | ec476b11-0b3c-4139-b1eb-a3daa76bc271 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE SODIUM |
| Methotrexate | METHOTREXATE SODIUM | Bryant Ranch Prepack | c7592288-ac24-46c6-8cec-9abe23d7e81e | 2023-12-07 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE SODIUM |
| Methotrexate | METHOTREXATE SODIUM | Fresenius Kabi USA, LLC | b585f621-f6c9-4735-ab61-bd1b401f3df0 | 2021-03-24 | Boxed warning, Adverse reactions | METHOTREXATE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.