Details for New Drug Application (NDA): 200197
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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 200197
Tradename: | MYCOPHENOLATE MOFETIL |
Applicant: | Alkem Labs Ltd |
Ingredient: | mycophenolate mofetil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 200197
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | CAPSULE;ORAL | 200197 | ANDA | AvPAK | 50268-557 | 50268-557-15 | 50 BLISTER PACK in 1 BOX (50268-557-15) / 1 CAPSULE in 1 BLISTER PACK (50268-557-11) |
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | CAPSULE;ORAL | 200197 | ANDA | Ascend Laboratories, LLC | 67877-266 | 67877-266-01 | 100 CAPSULE in 1 BOTTLE (67877-266-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
Approval Date: | Jun 13, 2013 | TE: | AB | RLD: | No |
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