Details for New Drug Application (NDA): 216390
✉ Email this page to a colleague
NDA 216390 describes MYCOPHENOLATE MOFETIL HYDROCHLORIDE, which is a drug marketed by Amneal, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, Rising, and Zydus Pharms, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL HYDROCHLORIDE profile page.
The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 216390
| Tradename: | MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
| Applicant: | Onesource Specialty |
| Ingredient: | mycophenolate mofetil hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 216390 | ANDA | ARMAS PHARMACEUTICALS INC | 72485-415 | 72485-415-04 | 4 VIAL in 1 CARTON (72485-415-04) / 20 mL in 1 VIAL |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 216390 | ANDA | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-000 | 83270-000-04 | 4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Dec 23, 2022 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
