APPLICATION
ANDA090151
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-30
LATEST ACTION
2019-11-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG · TABLET · ORAL
Approval history
2019-11-15Labeling · Supplement 6 · standardAP
2019-11-15Labeling · Supplement 5 · standardAP
2016-04-28Labeling · Supplement 4 · standardAP
2015-11-17Labeling · Supplement 3 · standardAP
2013-08-15Labeling · Supplement 2 · standardAP
2013-08-15Labeling · Supplement 1 · standardAP
2012-04-30OriginalAP
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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