Application 210737

Type
NDA
Sponsor
CUMBERLAND PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REDITREXMETHOTREXATESOLUTION;SUBCUTANEOUS7.5MG/0.3ML (7.5MG/0.3ML)NoNo
002REDITREXMETHOTREXATESOLUTION;SUBCUTANEOUS10MG/0.4ML (10MG/0.4ML)NoNo
003REDITREXMETHOTREXATESOLUTION;SUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)NoNo
004REDITREXMETHOTREXATESOLUTION;SUBCUTANEOUS15MG/0.6ML (15MG/0.6ML)NoNo
005REDITREXMETHOTREXATESOLUTION;SUBCUTANEOUS17.5MG/0.7ML (17.5MG/0.7ML)NoNo
006REDITREXMETHOTREXATESOLUTION;SUBCUTANEOUS20MG/0.8ML (20MG/0.8ML)NoNo
007REDITREXMETHOTREXATESOLUTION;SUBCUTANEOUS22.5MG/ML (22.5MG/ML)NoNo
008REDITREXMETHOTREXATESOLUTION;SUBCUTANEOUS25MG/1ML (25MG/1ML)NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210737-001REDITREXMETHOTREXATE7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-002REDITREXMETHOTREXATE10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-003REDITREXMETHOTREXATE12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-004REDITREXMETHOTREXATE15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-005REDITREXMETHOTREXATE17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-006REDITREXMETHOTREXATE20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-007REDITREXMETHOTREXATE22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-008REDITREXMETHOTREXATE25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2784e616aacf4f…
2026-09-14 22:38:342026-08N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2784e616aacf4f…
2026-09-14 22:38:342026-08N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2784e616aacf4f…
2026-09-14 22:38:342026-08N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2784e616aacf4f…
2026-09-14 22:38:342026-08N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2784e616aacf4f…
2026-09-14 22:38:342026-08N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2784e616aacf4f…
2026-09-14 22:38:342026-08N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2784e616aacf4f…
2026-09-14 22:38:342026-08N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2784e616aacf4f…
2026-08-18 06:07:402026-07N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATEHikma Pharmaceuticals USA Inc.3989d30d-56e5-4e8d-9379-c30fecc894f22023-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHOTREXATE

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66220-807RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-807RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-807RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-810RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-810RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-810RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-812RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-812RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-812RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-815RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-815RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-815RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-817RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-817RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-817RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-820RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-820RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-820RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-822RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-822RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-822RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-825RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-825RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
66220-825RediTrexmethotrexateCumberland Pharmaceuticals Inc.NDACurrent
69605-807RediTrexmethotrexateCENEXI - BLANDACurrent
69605-810RediTrexmethotrexateCENEXI - BLANDACurrent
69605-812RediTrexmethotrexateCENEXI - BLANDACurrent
69605-815RediTrexmethotrexateCENEXI - BLANDACurrent
69605-817RediTrexmethotrexateCENEXI - BLANDACurrent
69605-820RediTrexmethotrexateCENEXI - BLANDACurrent
69605-822RediTrexmethotrexateCENEXI - BLANDACurrent
69605-825RediTrexmethotrexateCENEXI - BLANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73920SUPPL 2023-03-31
73910SUPPL 2023-03-31
62371ORIG2020-03-31
62370ORIG2020-03-31
61117ORIG2019-12-02
61116ORIG2019-12-02
61107ORIG2019-11-29
61106ORIG2019-11-29