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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N210737-001 | REDITREX | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210737-002 | REDITREX | 10MG/0.4ML (10MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210737-003 | REDITREX | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210737-004 | REDITREX | 15MG/0.6ML (15MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210737-005 | REDITREX | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210737-006 | REDITREX | 20MG/0.8ML (20MG/0.8ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210737-007 | REDITREX | 22.5MG/ML (22.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210737-008 | REDITREX | 25MG/1ML (25MG/1ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N210737-001 | REDITREX | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210737-002 | REDITREX | 10MG/0.4ML (10MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210737-003 | REDITREX | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210737-004 | REDITREX | 15MG/0.6ML (15MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210737-005 | REDITREX | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210737-006 | REDITREX | 20MG/0.8ML (20MG/0.8ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210737-007 | REDITREX | 22.5MG/ML (22.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210737-008 | REDITREX | 25MG/1ML (25MG/1ML) | SOLUTION / SUBCUTANEOUS | RLD | 2019-11-27 | caaa826d4ba7… | |
| 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… |
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 | Golden State Medical Supply, Inc. | 6f14ced9-c16b-905a-e053-2a91aa0a031e | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Safecor Health LLC | f177e6fa-c482-432d-8208-937468ab3f10 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | AvPAK | 4992fdaa-b880-ee25-e063-6394a90af03b | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Chartwell RX, LLC | 2609da8f-80dc-448e-8eba-35d11488ce7f | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Rasuvo | METHOTREXATE | Medexus Pharma Inc. | d0075461-0e7e-4967-9c9b-d6440e912c0e | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Hospira, Inc. | 0e30eaef-5a09-4104-8a11-c32933eadeab | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Mylan Institutional Inc. | 8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Hikma Pharmaceuticals USA Inc. | b080eb92-fc72-4ce6-a7ab-3f9ce2415526 | 2025-07-17 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Teva Parenteral Medicines, Inc. | 346ec9ce-dc98-4a55-b55e-d3af11f2d703 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| METHOTREXATE | METHOTREXATE | Eugia US LLC | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2025-07-10 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Hospira, Inc. | bd287e89-32f9-4396-95fa-4b562869f476 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Hospira, Inc. | 0d63ba29-b692-41b4-87e8-351265c8273f | 2025-06-10 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Coupler LLC | 2f20d43e-a4b3-a839-e063-6394a90ace38 | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Otrexup | METHOTREXATE | Antares Pharma, Inc. | 9ab8ce16-f7de-41d4-a4c8-1c742621b6d5 | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | NuCare Pharmaceuticals, Inc. | 2b61822e-b488-5eaf-e063-6394a90a2dcd | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Zydus Lifesciences Limited | 59ea7b32-2b6d-4197-92c3-015936f04ebe | 2024-12-05 | METHOTREXATE | |
| Methotrexate | METHOTREXATE | Bryant Ranch Prepack | e6611304-4622-4b2e-9b94-57fbad023ae2 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Hikma Pharmaceuticals USA Inc. | 8593f7fc-eabe-44ae-bb05-b3d7d408e4f7 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| Methotrexate | METHOTREXATE | Proficient Rx LP | a76808f0-38a7-4b54-a4fb-3584f9058ae5 | 2024-08-01 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
| METHOTREXATE | METHOTREXATE | Alembic Pharmaceuticals Limited | ff55c573-dc84-4ff3-9d10-2b24c47dd679 | 2024-06-07 | Boxed warning, Warnings, Adverse reactions | METHOTREXATE |
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 |
|---|---|---|---|---|---|
| 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 |