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FDA NDA · NDA210910

AEMCOLO

Sponsor: COSMO TECHNOLOGIES

APPLICATION
NDA210910
TYPE
NDA
ORIGINAL APPROVAL
2018-11-16
LATEST ACTION
2019-07-12
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

AEMCOLO · ReferenceDiscontinued
RIFAMYCIN SODIUM EQ 194MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

2019-07-12Labeling · Supplement 1 · standard — Letter ↗AP
2018-11-16Type 1 - New Molecular Entity · Original · priority — 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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