Details for New Drug Application (NDA): 210370
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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 210370
Tradename: | MYCOPHENOLATE MOFETIL |
Applicant: | Vistapharm |
Ingredient: | mycophenolate mofetil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210370
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | FOR SUSPENSION;ORAL | 210370 | ANDA | VistaPharm, LLC | 66689-307 | 66689-307-08 | 1 BOTTLE, PLASTIC in 1 CARTON (66689-307-08) / 250 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/ML | ||||
Approval Date: | Feb 12, 2019 | TE: | AB | RLD: | No |
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