Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022421
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 AB Yes Yes
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

MIRAPEX ER

TABLET, EXTENDED RELEASE;ORAL; 0.375MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022421 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201963 ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204518 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202206 ANCHEN PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203354 DR REDDYS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206156 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202353 SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202891 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 0.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022421 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201963 ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204518 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202206 ANCHEN PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203354 DR REDDYS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206156 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202353 SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202891 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022421 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201963 ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204518 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202206 ANCHEN PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203354 DR REDDYS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206156 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202353 SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202891 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022421 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201963 ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204518 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202206 ANCHEN PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203354 DR REDDYS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206156 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202353 SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202891 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 4.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022421 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201963 ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204518 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202206 ANCHEN PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203354 DR REDDYS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206156 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202353 SANDOZ INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202891 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 2.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022421 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203615 ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204518 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202206 ANCHEN PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206156 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202891 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 3.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022421 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203615 ACTAVIS ELIZABETH
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204518 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202206 ANCHEN PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206156 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202891 ZYDUS PHARMS

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