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Details for New Drug Application (NDA): 050791
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NDA 050791 describes MYFORTIC, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the MYFORTIC profile page.
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.
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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