Details for New Drug Application (NDA): 090606
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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 090606
Tradename: | MYCOPHENOLATE MOFETIL |
Applicant: | Amneal |
Ingredient: | mycophenolate mofetil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090606
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 090606 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2135 | 60219-2135-1 | 100 TABLET in 1 BOTTLE (60219-2135-1) |
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 090606 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2135 | 60219-2135-5 | 500 TABLET in 1 BOTTLE (60219-2135-5) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jul 16, 2010 | TE: | RLD: | No |
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