Details for New Drug Application (NDA): 203575
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The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE 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 203575
Tradename: | MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
Applicant: | Endo Operations |
Ingredient: | mycophenolate mofetil hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 203575
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 203575 | ANDA | Endo USA, Inc. | 42023-172 | 42023-172-04 | 4 VIAL in 1 CARTON (42023-172-04) / 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Oct 28, 2016 | TE: | AP | RLD: | No |
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