Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210737
Company: CUMBERLAND PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REDITREX METHOTREXATE 7.5MG/0.3ML (7.5MG/0.3ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
REDITREX METHOTREXATE 10MG/0.4ML (10MG/0.4ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
REDITREX METHOTREXATE 12.5MG/0.5ML (12.5MG/0.5ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
REDITREX METHOTREXATE 15MG/0.6ML (15MG/0.6ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
REDITREX METHOTREXATE 17.5MG/0.7ML (17.5MG/0.7ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
REDITREX METHOTREXATE 20MG/0.8ML (20MG/0.8ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
REDITREX METHOTREXATE 22.5MG/ML (22.5MG/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
REDITREX METHOTREXATE 25MG/1ML (25MG/1ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/2019 ORIG-2 Approval Efficacy STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210737Orig1s000,Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210737Orig1s000, 210737Orig2s000TOC.cfm
11/27/2019 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210737Orig1s000,Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210737Orig1s000, 210737Orig2s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/27/2019 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf
11/27/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf

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