Drugs@FDA: FDA Approved Drug Products

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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 Prescription AB Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription AB Yes Yes
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription AB Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.25MG TABLET;ORAL Discontinued None No No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription AB Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription AB Yes No
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;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
07/01/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Letter (PDF)
Review
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667a_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667.cfm https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/020667Orig1s000_LBL.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/10/2018 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020667s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020667Orig1s036,022421Orig1s017ltr.pdf
07/28/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s034ltr.pdf
01/14/2016 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s033ltr.pdf
11/20/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/11/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/27/2015 SUPPL-30 Labeling-Package Insert Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf
03/01/2013 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020667s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020667Orig1s029ltr.pdf
08/31/2012 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s027ltr.pdf
05/13/2011 SUPPL-25 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020667s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020667s025ltr.pdf
07/17/2012 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
07/17/2012 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
07/17/2012 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
07/17/2012 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
07/17/2012 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
12/31/2008 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf
12/31/2008 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf
12/31/2008 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf
11/07/2006 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf
11/07/2006 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf
12/04/2002 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/06/2003 SUPPL-8 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20667slr008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020667_S008_MirapexTOC.cfm
09/03/1999 SUPPL-7 Labeling

Label is not available on this site.

11/18/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/12/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/19/1998 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

MIRAPEX

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 078894 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090151 APOTEX INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 077724 BARR
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 202164 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 077854 MYLAN
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 091683 SUN PHARM INDS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090241 TEVA PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 207011 UNICHEM LABS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 078894 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090151 APOTEX INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 077724 BARR
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 211088 CSPC OUYI
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 202164 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 077854 MYLAN
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 091683 SUN PHARM INDS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090241 TEVA PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 207011 UNICHEM LABS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 078894 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090151 APOTEX INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 077724 BARR
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 211088 CSPC OUYI
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 202164 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 077854 MYLAN
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 091683 SUN PHARM INDS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090241 TEVA PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 207011 UNICHEM LABS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 078894 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090151 APOTEX INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 077724 BARR
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 211088 CSPC OUYI
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 202164 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 077854 MYLAN
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 091683 SUN PHARM INDS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090241 TEVA PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 207011 UNICHEM LABS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 078894 ALEMBIC PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090151 APOTEX INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 077724 BARR
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 211088 CSPC OUYI
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 202164 MACLEODS PHARMS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 077854 MYLAN
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 091683 SUN PHARM INDS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090241 TEVA PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 207011 UNICHEM LABS LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 0.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090151 APOTEX INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 211088 CSPC OUYI
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090764 MYLAN
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 091683 SUN PHARM INDS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090241 TEVA PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 207011 UNICHEM LABS LTD

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