APPLICATION
ANDA210201
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-02
LATEST ACTION
2024-09-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MISOPROSTOLPrescription
MISOPROSTOL 0.2MG · TABLET · ORAL
MISOPROSTOLPrescription
MISOPROSTOL 0.1MG · TABLET · ORAL
Approval history
2024-09-05Manufacturing (CMC) · Supplement 2 · unknownAP
2019-07-02UNKNOWN · Original · standardAP
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.