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FDA NDA · NDA050791

MYFORTIC

mycophenolic acid

Sponsor: NOVARTIS

APPLICATION
NDA050791
TYPE
NDA
ORIGINAL APPROVAL
2004-02-27
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

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

Approval history

2026-07-29REMS · Supplement 43 — Letter ↗AP
2026-07-29Labeling · Supplement 42 · standard — Letter ↗AP
2025-06-27Labeling · Supplement 40 · standard — Letter ↗AP
2024-08-13REMS · Supplement 38 — Letter ↗AP
2022-03-15Labeling · Supplement 35 · standard — Letter ↗AP
2021-08-11REMS · Supplement 36 — Letter ↗AP
2021-04-21REMS · Supplement 34 — Letter ↗AP
2021-01-15REMS · Supplement 33 — Letter ↗AP
2020-11-03Manufacturing (CMC) · Supplement 32 — Letter ↗AP
2020-04-28Labeling · Supplement 30 · standard — Letter ↗AP
2015-12-23Manufacturing (CMC) · Supplement 23 · standardAP
2015-11-13REMS · Supplement 22 — Letter ↗AP
2015-10-27Labeling · Supplement 24 · standard — Label ↗AP
2015-08-04Manufacturing (CMC) · Supplement 21 · standard — Letter ↗AP
2013-09-27Labeling · Supplement 18 · standard — Label ↗AP
2013-09-27REMS · Supplement 19 — Letter ↗AP
2013-05-01Manufacturing (CMC) · Supplement 16 · standardAP
2013-05-01Labeling · Supplement 12 · standard — Label ↗AP
2013-02-08Manufacturing (CMC) · Supplement 15 · standardAP
2012-09-25Labeling · Supplement 5 · standard — Letter ↗AP
2012-06-22Labeling · Supplement 14 · standard — Label ↗AP
2010-10-27Labeling · Supplement 11 · unknown — Label ↗AP
2009-10-08Labeling · Supplement 8 · unknown — Label ↗AP
2009-07-10Labeling · Supplement 7 · standard — Label ↗AP
2009-03-27Labeling · Supplement 6 · standard — Letter ↗AP
2008-12-15Labeling · Supplement 4 · standard — Label ↗AP
2008-05-09Labeling · Supplement 2 · standard — Label ↗AP
2007-11-02Labeling · Supplement 1 · standard — Label ↗AP
2004-02-27Type 2 - New Active Ingredient · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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