← FDA DRUG APPROVALS

FDA ANDA · ANDA214630

MYCOPHENOLIC ACID

Sponsor: BIOCON PHARMA

APPLICATION
ANDA214630
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-29
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 14AP
2024-08-13REMS · Supplement 7AP
2023-01-10Labeling · Supplement 3 · standardAP
2021-11-29UNKNOWN · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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