APPLICATION
ANDA090781
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-08
LATEST ACTION
2023-05-10
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
2023-05-10Labeling · Supplement 10 · standardAP
2023-05-10Labeling · Supplement 9 · standardAP
2019-11-21Labeling · Supplement 8 · standardAP
2019-11-21Labeling · Supplement 7 · standardAP
2016-05-10Labeling · Supplement 5 · standardAP
2015-09-22Labeling · Supplement 4 · standardAP
2015-09-22Labeling · Supplement 3 · standardAP
2015-09-11Manufacturing (CMC) · Supplement 2AP
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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