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FDA ANDA · ANDA203615

PRAMIPEXOLE DIHYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA203615
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-14
LATEST ACTION
2023-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 3.75MG · TABLET, EXTENDED RELEASE · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 2.25MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-05-31Labeling · Supplement 3 · standardAP
2017-01-03UNKNOWN · OriginalAP
2016-10-14UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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