Home Applications 210737 Application 210737
Type NDA
Sponsor CUMBERLAND PHARMS Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table 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.
Product history page 1 of 8 · 320 observed states.
Captured, Edition, Application-product table 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.
Matched openFDA labels page 3 of 3 · 41 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 32 matching rows.
NDC, Name, Nonproprietary name table 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
Documents# Document, Submission type, Date table Document Submission type Date 73920 SUPPL 2023-03-31 73910 SUPPL 2023-03-31 62371 ORIG 2020-03-31 62370 ORIG 2020-03-31 61117 ORIG 2019-12-02 61116 ORIG 2019-12-02 61107 ORIG 2019-11-29 61106 ORIG 2019-11-29