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FDA ANDA · ANDA091053

ACARBOSE

Sponsor: NATCO PHARMA USA

APPLICATION
ANDA091053
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-06
LATEST ACTION
2016-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACARBOSEDiscontinued
ACARBOSE 100MG · TABLET · ORAL
ACARBOSEDiscontinued
ACARBOSE 25MG · TABLET · ORAL
ACARBOSEDiscontinued
ACARBOSE 50MG · TABLET · ORAL

Approval history

2016-03-24Labeling · Supplement 3 · standardAP
2016-03-24Labeling · Supplement 1 · standardAP
2011-01-06OriginalAP
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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