Details for New Drug Application (NDA): 203859
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NDA 203859 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 six suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL HYDROCHLORIDE profile page.
The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE is mycophenolate mofetil hydrochloride. There is one drug master file entry for this compound. Seven 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 is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 203859
| Tradename: | MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | mycophenolate mofetil hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203859
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 203859 | ANDA | Mylan Institutional LLC | 67457-386 | 67457-386-81 | 4 VIAL in 1 CARTON (67457-386-81) / 20 mL in 1 VIAL (67457-386-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Mar 31, 2017 | TE: | AP | RLD: | No | ||||
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