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FDA ANDA · ANDA076095

MISOPROSTOL

Sponsor: ANI PHARMS

APPLICATION
ANDA076095
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-10
LATEST ACTION
2022-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MISOPROSTOLPrescription
MISOPROSTOL 0.1MG · TABLET · ORAL
MISOPROSTOLPrescription
MISOPROSTOL 0.2MG · TABLET · ORAL

Approval history

2022-07-14Manufacturing (CMC) · Supplement 15 · unknownAP
2010-01-27Labeling · Supplement 12AP
2007-12-27Labeling · Supplement 4AP
2002-11-20Manufacturing (CMC) · Supplement 2AP
2002-11-20Manufacturing (CMC) · Supplement 1AP
2002-07-10Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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