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FDA ANDA · ANDA209180

ALOSETRON HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA209180
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-14
LATEST ACTION
2023-09-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALOSETRON HYDROCHLORIDEPrescription
ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE · TABLET · ORAL
ALOSETRON HYDROCHLORIDEPrescription
ALOSETRON HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL

Approval history

2023-09-08REMS · Supplement 6 — Letter ↗AP
2022-05-05REMS · Supplement 5AP
2021-10-18REMS · Supplement 4AP
2019-11-06Labeling · Supplement 1 · standardAP
2019-01-14UNKNOWN · Original · standardAP
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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