FDA ANDA · ANDA090764
PRAMIPEXOLE DIHYDROCHLORIDE
Sponsor: NATCO PHARMA
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APPLICATION
ANDA090764
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-09
LATEST ACTION
2026-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET · ORAL
Approval history
2026-10-16Labeling · Supplement 14 · standardAP
2024-03-19Labeling · Supplement 13 · standardAP
2024-03-19Labeling · Supplement 11 · standardAP
2024-03-19Labeling · Supplement 9 · standardAP
2024-03-19Labeling · Supplement 10 · standardAP
2015-11-05Labeling · Supplement 8 · standardAP
2015-11-05Labeling · Supplement 6 · standardAP
2013-08-08Labeling · Supplement 4 · standardAP
2010-04-09OriginalAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →