FDA Approval Activities for this Drug…

CellCept (mycophenolate mofetil hydrochloride) Intravenous, for injection/new injection, Roche Global Development NDA 50-758 8/12/98 11/12/98 CellCept Indication: Prophylaxis of organ rejection in patients receiving allogeneicrenal transplants and in patients receiving allogeneic cardiac transplants. CellCept (mycophenolate mofetil hydrochloride) Intravenous / Suspension / Capsules / Tablets, Hoffman La-Roche NDA 50-722/SE5-007, 50-723/SE5-004, 50-759/SE5-005 12/22/00 12/26/00 12/26/00 11/1/01 CellCept (mycophenolate mofetil hydrochloride) Intravenous / Suspension / Capsules / Tablets, Hoffman La-Roche, NDA 50-722/SE1-008, 50-723/SE1-006, 50-758/SE1-005, 50-759/SE1-008 2/28/03 3/10/03 3/11/03 | CellCept (mycophenolate mofetil hydrochloride) Intravenous / Suspension / Capsules / Tablets, Hoffman La-Roche NDA 50-722/SE1-005, 50-723/SE1-005, 50-758/SE1-004, 50-759/SE1-006 Myfortic (Mycophenolic Acid) Delayed-Release Tablets, Novartis Pharmaceuticals | CellCept Intravenous (mycophenolate mofetil hydrochloride) injection, Hoffmann-La Roche, Labeling Revision

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