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Details for New Drug Application (NDA): 050791
NDA 050791 describes MYFORTIC, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. 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. Eight 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. Eight 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: | 1 |
| 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) |
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 | ||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Feb 27, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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 | ||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Feb 27, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Novartis | MYFORTIC | mycophenolic acid | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Novartis | MYFORTIC | mycophenolic acid | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Novartis | MYFORTIC | mycophenolic acid | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Novartis | MYFORTIC | mycophenolic acid | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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