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FDA ANDA · ANDA206647

ALOSETRON HYDROCHLORIDE

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA206647
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-22
LATEST ACTION
2023-12-08
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

2023-12-08Labeling · Supplement 11 · standardAP
2023-09-08REMS · Supplement 16 — Letter ↗AP
2022-05-05REMS · Supplement 12AP
2021-10-18REMS · Supplement 9AP
2019-12-06Labeling · Supplement 4 · standardAP
2016-12-22UNKNOWN · Original · standard — Review ↗AP
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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