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FDA ANDA · ANDA077460

ROPINIROLE HYDROCHLORIDE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA077460
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-05
LATEST ACTION
2020-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 3MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
ROPINIROLE HYDROCHLORIDEDiscontinued
ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · ORAL

Approval history

2020-03-03Labeling · Supplement 8 · standardAP
2009-11-17Labeling · Supplement 4AP
2008-05-19Labeling · Supplement 2AP
2008-05-05Original — Label ↗AP
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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