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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090241
Company: HERITAGE PHARMA AVET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Discontinued None No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Discontinued None No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Discontinued None No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Discontinued None No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Discontinued None No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Discontinued None 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
03/10/2021 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/14/2011 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

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