Application 210737
- Type
- NDA
- Sponsor
- CUMBERLAND PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REDITREX | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 7.5MG/0.3ML (7.5MG/0.3ML) | No | No |
| 002 | REDITREX | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 10MG/0.4ML (10MG/0.4ML) | No | No |
| 003 | REDITREX | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | No | No |
| 004 | REDITREX | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 15MG/0.6ML (15MG/0.6ML) | No | No |
| 005 | REDITREX | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 17.5MG/0.7ML (17.5MG/0.7ML) | No | No |
| 006 | REDITREX | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 20MG/0.8ML (20MG/0.8ML) | No | No |
| 007 | REDITREX | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 22.5MG/ML (22.5MG/ML) | No | No |
| 008 | REDITREX | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 25MG/1ML (25MG/1ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210737-001 | REDITREX | METHOTREXATE | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | |
| N210737-002 | REDITREX | METHOTREXATE | 10MG/0.4ML (10MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | |
| N210737-003 | REDITREX | METHOTREXATE | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | |
| N210737-004 | REDITREX | METHOTREXATE | 15MG/0.6ML (15MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | |
| N210737-005 | REDITREX | METHOTREXATE | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | |
| N210737-006 | REDITREX | METHOTREXATE | 20MG/0.8ML (20MG/0.8ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | |
| N210737-007 | REDITREX | METHOTREXATE | 22.5MG/ML (22.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | |
| N210737-008 | REDITREX | METHOTREXATE | 25MG/1ML (25MG/1ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N210737-001 | REDITREX | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210737-002 | REDITREX | 10MG/0.4ML (10MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210737-003 | REDITREX | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210737-004 | REDITREX | 15MG/0.6ML (15MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210737-005 | REDITREX | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210737-006 | REDITREX | 20MG/0.8ML (20MG/0.8ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210737-007 | REDITREX | 22.5MG/ML (22.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210737-008 | REDITREX | 25MG/1ML (25MG/1ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210737-001 | REDITREX | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210737-002 | REDITREX | 10MG/0.4ML (10MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210737-003 | REDITREX | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210737-004 | REDITREX | 15MG/0.6ML (15MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210737-005 | REDITREX | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210737-006 | REDITREX | 20MG/0.8ML (20MG/0.8ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210737-007 | REDITREX | 22.5MG/ML (22.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210737-008 | REDITREX | 25MG/1ML (25MG/1ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210737-001 | REDITREX | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210737-002 | REDITREX | 10MG/0.4ML (10MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210737-003 | REDITREX | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210737-004 | REDITREX | 15MG/0.6ML (15MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210737-005 | REDITREX | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210737-006 | REDITREX | 20MG/0.8ML (20MG/0.8ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210737-007 | REDITREX | 22.5MG/ML (22.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210737-008 | REDITREX | 25MG/1ML (25MG/1ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210737-001 | REDITREX | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210737-002 | REDITREX | 10MG/0.4ML (10MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210737-003 | REDITREX | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210737-004 | REDITREX | 15MG/0.6ML (15MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210737-005 | REDITREX | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210737-006 | REDITREX | 20MG/0.8ML (20MG/0.8ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210737-007 | REDITREX | 22.5MG/ML (22.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210737-008 | REDITREX | 25MG/1ML (25MG/1ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210737-001 | REDITREX | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210737-002 | REDITREX | 10MG/0.4ML (10MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210737-003 | REDITREX | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210737-004 | REDITREX | 15MG/0.6ML (15MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210737-005 | REDITREX | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210737-006 | REDITREX | 20MG/0.8ML (20MG/0.8ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210737-007 | REDITREX | 22.5MG/ML (22.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210737-008 | REDITREX | 25MG/1ML (25MG/1ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | b8a1b40f171c… |
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 | METHOTREXATE | AvKARE | 757d6cef-6696-7a1c-8074-01258aaa8bdd | 2026-07-23 | Boxed warning, Adverse reactions | METHOTREXATE |
| Trexall | METHOTREXATE | Teva Women's Health LLC | e942f8db-510f-44d6-acb5-b822196f5e8c | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Bryant Ranch Prepack | b6e61c50-024a-494f-b04c-100fb371a837 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| JYLAMVO | METHOTREXATE | SHORLA ONCOLOGY INC. | 96e931f5-51ae-4bdf-a441-bb0dd26d4c0e | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Bryant Ranch Prepack | 0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Teva Pharmaceuticals USA, Inc. | 9b34b1d8-d125-41a2-9f6f-3fab67b573bd | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Major Pharmaceuticals | 2a6afc4c-819d-4ba9-8040-4504519c116a | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Xatmep | METHOTREXATE | Azurity Pharmaceuticals, Inc. | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Accord Healthcare Inc. | 874c7f43-a3be-4236-89cc-24c44e3c5813 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| METHOTREXATE | METHOTREXATE | Bryant Ranch Prepack | 4a04756f-e1c9-4d1e-b309-7be31c9176d6 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Bryant Ranch Prepack | 4741a44f-0d0b-4380-84f6-231a8d1560fb | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| METHOTREXATE | METHOTREXATE | Alembic Pharmaceuticals Inc. | 04a95db9-a124-4b97-bd71-1c37a6b3b0c8 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Zydus Pharmaceuticals USA Inc. | 948e0bab-6524-4b87-9853-1799d4415558 | 2026-05-09 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Mylan Pharmaceuticals Inc. | 70c09984-2b36-424f-8b27-3fd0cd4e833d | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Aurobindo Pharma Limited | 09931d44-a3f8-49dc-a3f2-b527ee4214bf | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | NuCare Pharmaceuticals, Inc. | 50b2cfc7-dfe4-4406-e063-6294a90a2527 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| METHOTREXATE | METHOTREXATE | Alembic Pharmaceuticals Inc. | a63364d5-4dfa-49d7-8a5e-c8959ae1d37a | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| METHOTREXATE | METHOTREXATE | Alembic Pharmaceuticals Limited | e98b2abd-8068-482e-9ce3-1ab262f0838e | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Golden State Medical Supply, Inc. | 6f14ced9-c16b-905a-e053-2a91aa0a031e | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | A-S Medication Solutions | 22e10810-16fb-4c84-bccf-972405b77ef8 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66220-807 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-807 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-807 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-810 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-810 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-810 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-812 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-812 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-812 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-815 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-815 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-815 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-817 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-817 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-817 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-820 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-820 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-820 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-822 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-822 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-822 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-825 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-825 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-825 | RediTrex | methotrexate | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 69605-807 | RediTrex | methotrexate | CENEXI - BLA | NDA | Current |
| 69605-810 | RediTrex | methotrexate | CENEXI - BLA | NDA | Current |
| 69605-812 | RediTrex | methotrexate | CENEXI - BLA | NDA | Current |
| 69605-815 | RediTrex | methotrexate | CENEXI - BLA | NDA | Current |
| 69605-817 | RediTrex | methotrexate | CENEXI - BLA | NDA | Current |
| 69605-820 | RediTrex | methotrexate | CENEXI - BLA | NDA | Current |
| 69605-822 | RediTrex | methotrexate | CENEXI - BLA | NDA | Current |
| 69605-825 | RediTrex | methotrexate | CENEXI - BLA | NDA | Current |