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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 | CellCept (mycophenolate mofetil) Capsules, Hoffmann-La Roche, Labeling Revision | CellCept (mycophenolate mofetil) Tablets, Hoffmann-La Roche, Labeling Revision | CellCept (mycophenolate mofetil hydrochloride) Injection, Hoffmann-La Roche, Labeling Revision | CellCept (mycophenolate mofetil hydrochloride) Oral Suspension, Hoffmann-La Roche, Labeling Revision | CellCept (mycophenolate mofetil) Capsules, Roche Palo, Labeling Revision | CellCept (mycophenolate mofetil) Tablets, Roche Palo, Labeling Revision | CellCept (mycophenolate mofetil hydrochloride), Intravenous, Roche Palo, Labeling Revision | CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo, Labeling Revision | Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharma, Labeling Revision | CellCept (mycophenolate mofetil) Capsules, Roche Palo Alto, Labeling Revision | CellCept (mycophenolate mofetil) Tablets, Roche Palo Alto, Labeling Revision | CellCept (mycophenolate mofetil hydrochloride) Intravenous, Roche Palo Alto, Labeling Revision | CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto, Labeling Revision | Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Mycophenolate Mofetil Capsules, Roxane Laboratories, Inc., Approval | Mycophenolate Mofetil Tablets, Roxane Laboratories, Inc., Approval | Mycophenolate Mofetil Capsules, Sandoz Inc., Approval | Mycophenolate Mofetil Tablets, Sandoz Inc., Approval | Cellcept (mycophenolate mofetil) Capsules, Roche Palo Alto LLC, Labeling Revision | Cellcept (mycophenolate mofetil) Tablets, Roche Palo Alto LLC, Labeling Revision | Cellcept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto LLC, Labeling Revision | Cellcept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto LLC, Labeling Revision | Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | CellCept (mycophenolate mofetil) Capsules, Roche Palo Alto LLC, Labeling Revision | CellCept (mycophenolate mofetil) Tablets, Roche Palo Alto LLC, Labeling Revision | CellCept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto LLC, Labeling Revision | CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto LLC, Labeling Revision | Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Mycophenolate Mofetil Capsules, Apotex Inc., Approval | Mycophenolate Mofetil Tablets, Apotex Inc., Approval | Mycophenolate Mofetil Tablets, Mylan Pharmaceuticals Inc., Approval | Mycophenolate Mofetil Capsules, Accord Healthcare, Inc., Approval | Mycophenolate Mofetil Capsules, Teva Pharmaceuticals USA, Approval | Mycophenolate Mofetil Tablets, Teva Pharmaceuticals USA, Approval | Mycophenolate Mofetil Tablets, Zydus Pharmaceuticals USA Inc., Approval | CellCept (mycophenolate mofetil) Capsules, Roche Palo Alto LLC, Labeling Revision | CellCept (mycophenolate mofetil) Tablets, Roche Palo Alto LLC, Labeling Revision | CellCept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto LLC, Labeling Revision | CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto LLC, Labeling Revision | Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Cellcept (mycophenolate mofetil) Tablets, Roche Palo Alto, LLC, Manufacturing Change or Addition | CellCept (mycophenolate mofetil) Capsules, Roche Palo Alto, LLC, Labeling Revision | CellCept (mycophenolate mofetil) Tablets, Roche Palo Alto, LLC, Labeling Revision | CellCept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto, LLC, Labeling Revision | CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto, LLC, Labeling Revision | Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Mycophenolate Mofetil Capsules, Endo Pharmaceuticals, Inc., Approval | Mycophenolate Mofetil Tablets, Strides Inc., Approval | Mycophenolate Mofetil Tablets, Endo Pharmaceuticals Inc., Approval | Mycophenolate Mofetil Tablets, Dr. Reddy's Laboratories Ltd., Approval | Mycophenolate Mofetil Tablets, Dr. Reddy's Laboratories Ltd., Approval | Mycophenolate Mofetil Hydrochloride Injection, Bedford Laboratories, Tentative Approval | Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Mycophenolate Mofetil Capsules, Dr. Reddy's Laboratories, Ltd., Approval
  
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