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FDA ANDA · ANDA211173

MYCOPHENOLIC ACID

Sponsor: CONCORD BIOTECH LTD

APPLICATION
ANDA211173
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-13
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

MYCOPHENOLATE SODIUMPrescription
MYCOPHENOLATE SODIUM EQ 180MG BASE · TABLET, DELAYED RELEASE · ORAL
MYCOPHENOLATE SODIUMPrescription
MYCOPHENOLATE SODIUM EQ 360MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

2026-07-29REMS · Supplement 21AP
2024-08-13REMS · Supplement 16AP
2021-08-11REMS · Supplement 7AP
2021-04-21REMS · Supplement 6AP
2021-01-15REMS · Supplement 4AP
2019-12-13UNKNOWN · Original · standard — REMS ↗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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