Details for New Drug Application (NDA): 212130
✉ Email this page to a colleague
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 212130
Tradename: | MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
Applicant: | Meitheal |
Ingredient: | mycophenolate mofetil hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 212130
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 212130 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-803 | 71288-803-92 | 4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-92) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-91) |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 212130 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-803 | 71288-803-21 | 4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Jan 15, 2021 | TE: | AP | RLD: | No |
Complete Access Available with Subscription