Application 040385
- Type
- ANDA
- Sponsor
- BARR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TREXALL | METHOTREXATE SODIUM | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | TREXALL | METHOTREXATE SODIUM | TABLET;ORAL | EQ 7.5MG BASE | No | No |
| 003 | TREXALL | METHOTREXATE SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No |
| 004 | TREXALL | METHOTREXATE SODIUM | TABLET;ORAL | EQ 15MG BASE | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040385-001 | TREXALL | METHOTREXATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | ||
| A040385-002 | TREXALL | METHOTREXATE SODIUM | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | ||
| A040385-003 | TREXALL | METHOTREXATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | ||
| A040385-004 | TREXALL | METHOTREXATE SODIUM | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-02-18 07:12 UTC | 2024-02 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A040385-001 | TREXALL | EQ 5MG BASE | TABLET / ORAL | 2001-03-21 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040385-002 | TREXALL | EQ 7.5MG BASE | TABLET / ORAL | 2001-03-21 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040385-003 | TREXALL | EQ 10MG BASE | TABLET / ORAL | 2001-03-21 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040385-004 | TREXALL | EQ 15MG BASE | TABLET / ORAL | RS | 2001-03-21 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Trexall | METHOTREXATE | Teva Women's Health LLC | e942f8db-510f-44d6-acb5-b822196f5e8c | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 040385 ANDA040385 51285-369 51285-368 51285-367 51285-366 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51285-366 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-366 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-366 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-366 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-366 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-366 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-367 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-367 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-367 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-367 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-367 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-367 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-368 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-368 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-368 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-368 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-368 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-368 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-369 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-369 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-369 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-369 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-369 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |
| 51285-369 | Trexall | Methotrexate | Teva Women's Health, Inc. | ANDA | Current |