APPLICATION
ANDA090241
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-08
LATEST ACTION
2024-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 1MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG · TABLET · ORAL
Approval history
2024-03-27Labeling · Supplement 5 · standardAP
2021-03-10Labeling · Supplement 3 · standardAP
2021-03-10Labeling · Supplement 4 · standardAP
2021-03-10Labeling · Supplement 2 · standardAP
2011-06-14Manufacturing (CMC) · Supplement 1AP
2010-10-08OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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