Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207011
Company: UNICHEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription AB No 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
12/19/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

PRAMIPEXOLE DIHYDROCHLORIDE

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 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 077724 HERITAGE PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090241 HERITAGE PHARMA
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 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 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 077724 HERITAGE PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090241 HERITAGE PHARMA
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 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; 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 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 077724 HERITAGE PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090241 HERITAGE PHARMA
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 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 090241 HERITAGE PHARMA
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 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 207011 UNICHEM LABS LTD

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 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 077724 HERITAGE PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090241 HERITAGE PHARMA
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 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 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 077724 HERITAGE PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090241 HERITAGE PHARMA
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 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

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