APPLICATION
ANDA202353
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-04
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 3MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.375MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-02-28Labeling · Supplement 8 · standardAP
2023-07-13Labeling · Supplement 6 · standardAP
2020-12-22Labeling · Supplement 4 · standardAP
2020-12-22Labeling · Supplement 2 · standardAP
2020-12-22Labeling · Supplement 3 · standardAP
2016-05-10Labeling · Supplement 1 · standardAP
2014-12-04OriginalAP
2014-12-04OriginalTA
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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