Details for New Drug Application (NDA): 090253
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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 090253
Tradename: | MYCOPHENOLATE MOFETIL |
Applicant: | Accord Hlthcare |
Ingredient: | mycophenolate mofetil |
Patents: | 0 |
Suppliers and Packaging for NDA: 090253
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | CAPSULE;ORAL | 090253 | ANDA | Major Pharmaceuticals | 0904-7074 | 0904-7074-61 | 100 BLISTER PACK in 1 CARTON (0904-7074-61) / 1 CAPSULE in 1 BLISTER PACK |
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | CAPSULE;ORAL | 090253 | ANDA | Accord Healthcare Inc. | 16729-094 | 16729-094-01 | 100 CAPSULE in 1 BOTTLE (16729-094-01) |
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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