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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022421
Company: BOEHRINGER INGELHEIM

Other Important Information from FDA

Summary Review

Products on NDA 022421

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022421

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022421s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2024	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022421s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022421Orig1s023ltr.pdf
07/12/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022421Orig1s022ltr.pdf
01/30/2020	SUPPL-20	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022421Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022421Orig1s020ltr.pdf
05/10/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022421s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020667Orig1s036,022421Orig1s017ltr.pdf
07/28/2016	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s014ltr.pdf
01/14/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s013ltr.pdf
03/27/2015	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022421s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022421Orig1s010ltr.pdf
08/23/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/15/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/01/2013	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022421s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022421Orig1s007ltr.pdf
08/31/2012	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022421s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022421Orig1s006ltr.pdf
05/08/2014	SUPPL-3	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022421s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022421Orig1s003ltr.pdf
07/13/2010	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022421s001ltr.pdf

Labels for NDA 022421

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2024	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022421s023lbl.pdf
07/12/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf
01/30/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022421Orig1s020lbl.pdf
01/30/2020	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022421Orig1s020lbl.pdf
05/10/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022421s017lbl.pdf
07/28/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s014lbl.pdf
01/14/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s013lbl.pdf
03/27/2015	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022421s010lbl.pdf
05/08/2014	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022421s003lbl.pdf
03/01/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022421s007lbl.pdf
08/31/2012	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022421s006lbl.pdf
07/13/2010	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421s001lbl.pdf
02/19/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421lbl.pdf

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