Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203615
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG TABLET, EXTENDED RELEASE;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
01/03/2017 ORIG-2 Approval

Label is not available on this site.

10/14/2016 ORIG-1 Approval

Label is not available on this site.

PRAMIPEXOLE DIHYDROCHLORIDE

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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