Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208574
Company: TEVA PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROMIDEPSIN ROMIDEPSIN 10MG/2ML (5MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
ROMIDEPSIN ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION;INTRAVENOUS 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
03/13/2020 ORIG-2 Approval Efficacy STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574Orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208574Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208574Orig1s000,Orig2s000TOC.cfm
03/13/2020 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208574Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208574Orig1s000,Orig2s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/13/2020 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574Orig2lbl.pdf
03/13/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574s000lbl.pdf

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