APPLICATION
ANDA090865
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-08
LATEST ACTION
2023-07-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG · TABLET · ORAL
Approval history
2023-07-26Labeling · Supplement 21 · standardAP
2023-07-26Labeling · Supplement 22 · standardAP
2019-11-21Labeling · Supplement 18 · standardAP
2016-10-13Labeling · Supplement 17 · standardAP
2016-10-13Labeling · Supplement 15 · standardAP
2016-10-13Labeling · Supplement 11 · standardAP
2013-12-10Labeling · Supplement 6 · standardAP
2012-10-31Labeling · Supplement 5 · standardAP
2011-08-29Labeling · Supplement 2AP
2011-08-22Manufacturing (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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