Details for New Drug Application (NDA): 050759
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The generic ingredient in CELLCEPT is mycophenolate mofetil hydrochloride. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 050759
| Tradename: | CELLCEPT |
| Applicant: | Roche Palo |
| Ingredient: | mycophenolate mofetil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050759
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CELLCEPT | mycophenolate mofetil | FOR SUSPENSION;ORAL | 050759 | NDA | Genentech, Inc. | 0004-0261 | 0004-0261-29 | 1 BOTTLE, PLASTIC in 1 CARTON (0004-0261-29) / 225 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/ML | ||||
| Approval Date: | Oct 1, 1998 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 050759
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche Palo | CELLCEPT | mycophenolate mofetil | FOR SUSPENSION;ORAL | 050759-001 | Oct 1, 1998 | ⤷ Start Trial | ⤷ Start Trial |
| Roche Palo | CELLCEPT | mycophenolate mofetil | FOR SUSPENSION;ORAL | 050759-001 | Oct 1, 1998 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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