Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com