FDA ANDA · ANDA090419

MYCOPHENOLATE MOFETIL

Sponsor: APOTEX CORP

APPLICATION

ANDA090419

TYPE

ANDA

ORIGINAL APPROVAL

2009-04-22

LATEST ACTION

2015-11-13

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Discontinued

Products

MYCOPHENOLATE MOFETILDiscontinued

MYCOPHENOLATE MOFETIL 250MG · CAPSULE · ORAL

2015-11-13REMS · Supplement 9AP

2015-10-06Labeling · Supplement 8 · standardAP

2015-10-06Labeling · Supplement 10 · standardAP

2013-09-27Labeling · Supplement 7 · standardAP

2012-09-25REMS · Supplement 4AP

2012-08-31Labeling · Supplement 5 · standardAP

2010-04-16Labeling · Supplement 3AP

2010-04-15Labeling · Supplement 2AP

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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