Details for New Drug Application (NDA): 050758
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The generic ingredient in CELLCEPT 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 050758
Tradename: | CELLCEPT |
Applicant: | Roche Palo |
Ingredient: | mycophenolate mofetil hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 050758
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CELLCEPT | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 050758 | NDA | Genentech, Inc. | 0004-0298 | 0004-0298-09 | 4 VIAL in 1 CARTON (0004-0298-09) / 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Aug 12, 1998 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 050758
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Roche Palo | CELLCEPT | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 050758-001 | Aug 12, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Roche Palo | CELLCEPT | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 050758-001 | Aug 12, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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