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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201963
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG 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
04/21/2016 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/15/2020 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/15/2020 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/15/2020 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

PRAMIPEXOLE DIHYDROCHLORIDE

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 213444 NOVAST LABS
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 212797 XIAMEN LP PHARM CO
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 213444 NOVAST LABS
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 212797 XIAMEN LP PHARM CO
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 213444 NOVAST LABS
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 213444 NOVAST LABS
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 213444 NOVAST LABS
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
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