Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020667
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Discontinued None Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Discontinued None Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Discontinued None Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.25MG TABLET;ORAL Discontinued None No No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Discontinued None Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Discontinued None Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2021 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf
04/03/2020 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667s041lbl.pdf
01/30/2020 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf
01/30/2020 SUPPL-39 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf
05/10/2018 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020667s036lbl.pdf
07/28/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf
01/14/2016 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf
03/27/2015 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf
03/27/2015 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf
03/01/2013 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020667s029lbl.pdf
08/31/2012 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s027lbl.pdf
07/17/2012 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
07/17/2012 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
07/17/2012 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
07/17/2012 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
07/17/2012 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
05/13/2011 SUPPL-25 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020667s025lbl.pdf
12/31/2008 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf
12/31/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf
12/31/2008 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf
11/07/2006 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf
11/07/2006 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf

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