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FDA ANDA · ANDA200652

ALOSETRON HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA200652
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-04
LATEST ACTION
2023-09-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-09-08REMS · Supplement 9 — Letter ↗AP
2022-05-05REMS · Supplement 8AP
2021-10-18REMS · Supplement 7 — Letter ↗AP
2019-12-06Labeling · Supplement 5 · standardAP
2016-11-22REMS · Supplement 4 — Letter ↗AP
2016-03-24REMS · Supplement 3AP
2016-01-07REMS · Supplement 2AP
2015-05-04Not Applicable · Original — 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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