APPLICATION
ANDA077532
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-07
LATEST ACTION
2019-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACARBOSEPrescription
ACARBOSE 50MG · TABLET · ORAL
ACARBOSEPrescription
ACARBOSE 100MG · TABLET · ORAL
ACARBOSEPrescription
ACARBOSE 25MG · TABLET · ORAL
Approval history
2019-09-25Labeling · Supplement 8 · standardAP
2013-05-13Labeling · Supplement 6 · standardAP
2009-12-01Labeling · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.