← FDA DRUG APPROVALS

FDA ANDA · ANDA202633

PRAMIPEXOLE DIHYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA202633
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-26
LATEST ACTION
2024-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 1MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG · TABLET · ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPrescription
PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG · TABLET · ORAL

Approval history

2024-03-05Labeling · Supplement 14 · standardAP
2021-03-12Labeling · Supplement 9 · standardAP
2021-03-12Labeling · Supplement 13 · standardAP
2021-03-12Labeling · Supplement 11 · standardAP
2021-03-12Labeling · Supplement 8 · standardAP
2016-04-28Labeling · Supplement 7 · standardAP
2015-09-22Labeling · Supplement 5 · standardAP
2015-09-22Labeling · Supplement 1 · standardAP
2012-10-26UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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