Details for New Drug Application (NDA): 065520
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The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 065520
Tradename: | MYCOPHENOLATE MOFETIL |
Applicant: | Mylan |
Ingredient: | mycophenolate mofetil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065520
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | CAPSULE;ORAL | 065520 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2250 | 0378-2250-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-01) |
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | CAPSULE;ORAL | 065520 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2250 | 0378-2250-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
Approval Date: | May 4, 2009 | TE: | AB | RLD: | No |
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