Details for New Drug Application (NDA): 050791
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The generic ingredient in MYFORTIC is mycophenolic sodium. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolic sodium profile page.
Summary for 050791
Tradename: | MYFORTIC |
Applicant: | Novartis |
Ingredient: | mycophenolic sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 050791
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791 | NDA | Novartis Pharmaceuticals Corporation | 0078-0385 | 0078-0385-66 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66) |
MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791 | NDA | Novartis Pharmaceuticals Corporation | 0078-0386 | 0078-0386-66 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 180MG BASE | ||||
Approval Date: | Feb 27, 2004 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 360MG BASE | ||||
Approval Date: | Feb 27, 2004 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 050791
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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