APPLICATION
ANDA206156
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-24
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 4.5MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 3MG · 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
2025-08-01Labeling · Supplement 21 · standardAP
2025-08-01Labeling · Supplement 34 · standardAP
2023-06-07Labeling · Supplement 25 · standardAP
2020-10-29Labeling · Supplement 16 · standardAP
2020-10-29Labeling · Supplement 10 · standardAP
2020-10-29Labeling · Supplement 2 · standardAP
2017-01-23UNKNOWN · Original · standardAP
2016-06-24UNKNOWN · Original · standardAP
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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