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Details for New Drug Application (NDA): 050791
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The generic ingredient in MYFORTIC is mycophenolic acid. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the mycophenolic acid profile page.
Summary for 050791
Tradename: | MYFORTIC |
Applicant: | Novartis |
Ingredient: | mycophenolic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 050791
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYFORTIC | mycophenolic acid | 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 acid | TABLET, DELAYED RELEASE;ORAL | 050791 | NDA | Novartis Pharmaceuticals Corporation | 0078-0386 | 0078-0386-66 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66) |
Paragraph IV (Patent) Challenges for 050791
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MYFORTIC | TABLET, DELAYED RELEASE;ORAL | mycophenolic acid | 050791 | 2009-06-03 |
MYFORTIC | TABLET, DELAYED RELEASE;ORAL | mycophenolic acid | 050791 | 2009-02-02 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 180MG | ||||
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 | 360MG | ||||
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 acid | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | Start Trial | Start Trial |
Novartis | MYFORTIC | mycophenolic acid | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | Start Trial | Start Trial |
Novartis | MYFORTIC | mycophenolic acid | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | Start Trial | Start Trial |
Novartis | MYFORTIC | mycophenolic acid | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | Start Trial | Start Trial |
Novartis | MYFORTIC | mycophenolic acid | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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