Details for New Drug Application (NDA): 217937
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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. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 217937
Tradename: | MYCOPHENOLATE MOFETIL |
Applicant: | Aurobindo Pharma |
Ingredient: | mycophenolate mofetil |
Patents: | 0 |
Suppliers and Packaging for NDA: 217937
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 217937 | ANDA | Aurobindo Pharma Limited | 59651-638 | 59651-638-01 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01) |
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 217937 | ANDA | Aurobindo Pharma Limited | 59651-638 | 59651-638-05 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 20, 2024 | TE: | AB | RLD: | No |
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