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FDA ANDA · ANDA201963

PRAMIPEXOLE DIHYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA201963
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-21
LATEST ACTION
2023-06-16
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

2023-06-16Labeling · Supplement 6 · standardAP
2020-10-15Labeling · Supplement 1 · standardAP
2020-10-15Labeling · Supplement 4 · standardAP
2020-10-15Labeling · Supplement 2 · standardAP
2016-04-21Not Applicable · OriginalAP
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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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