APPLICATION
ANDA078920
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-06
LATEST ACTION
2020-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG · TABLET · ORAL
Approval history
2020-12-22Labeling · Supplement 18 · standardAP
2019-11-15Labeling · Supplement 12 · standardAP
2019-11-15Labeling · Supplement 10 · standardAP
2019-11-15Labeling · Supplement 15 · standardAP
2019-11-15Labeling · Supplement 9 · standardAP
2019-11-15Labeling · Supplement 14 · standardAP
2013-11-27Labeling · Supplement 6 · standardAP
2013-11-27Labeling · Supplement 5 · standardAP
2012-05-15Labeling · Supplement 4AP
2012-05-09Manufacturing (CMC) · Supplement 1AP
2010-07-06OriginalAP
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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