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FDA ANDA · ANDA091450

PRAMIPEXOLE DIHYDROCHLORIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA091450
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-08
LATEST ACTION
2013-07-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 1MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEDiscontinued
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG · TABLET · ORAL

Approval history

2013-07-19Labeling · Supplement 2 · standardAP
2013-07-19Labeling · Supplement 3 · standardAP
2010-10-08OriginalAP
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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