Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022514
Company: BOEHRINGER INGELHEIM

• Other Important Information from FDA

• Summary Review

Products on NDA 022514

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022514

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)	See NDA 022421 for the most up-to-date labeling	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

Labels for NDA 022514

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2010	ORIG-1	Approval	Label (PDF)	See NDA 022421 for the most up-to-date labeling	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022514lbl.pdf