FDA.report

Application 210737

Type
NDA
Sponsor
CUMBERLAND PHARMS

Related Records

Application Products

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

NDC Listings For This Application

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

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