Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090865
Company: TORRENT PHARMS
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
10/08/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2019 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

10/13/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

10/13/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/13/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/10/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/31/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/29/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

08/22/2011 SUPPL-1 Labeling-Package Insert

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 202633 AUROBINDO PHARMA LTD
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 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 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
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 202633 AUROBINDO PHARMA LTD
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 211088 RISING
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 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
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 202633 AUROBINDO PHARMA LTD
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 211088 RISING
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 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
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 202633 AUROBINDO PHARMA LTD
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 211088 RISING
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 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090151 ZENNOVA

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 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 211088 RISING
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 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
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 202633 AUROBINDO PHARMA LTD
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 211088 RISING
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 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

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