Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022514
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/19/2010 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022514lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022514s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022514_mirapex_er_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022514s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/19/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022514lbl.pdf

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