Details for New Drug Application (NDA): 050723
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The generic ingredient in CELLCEPT 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 050723
Tradename: | CELLCEPT |
Applicant: | Roche Palo |
Ingredient: | mycophenolate mofetil |
Patents: | 0 |
Suppliers and Packaging for NDA: 050723
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CELLCEPT | mycophenolate mofetil | TABLET;ORAL | 050723 | NDA | Genentech, Inc. | 0004-0260 | 0004-0260-01 | 1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
CELLCEPT | mycophenolate mofetil | TABLET;ORAL | 050723 | NDA | Genentech, Inc. | 0004-0260 | 0004-0260-43 | 1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-43) / 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 19, 1997 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 050723
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Roche Palo | CELLCEPT | mycophenolate mofetil | TABLET;ORAL | 050723-001 | Jun 19, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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