Details for New Drug Application (NDA): 021526
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The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
Summary for 021526
Tradename: | RANEXA |
Applicant: | Menarini Intl |
Ingredient: | ranolazine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021526
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526 | NDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-880 | 43353-880-83 | 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-880-83) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
Approval Date: | Feb 12, 2007 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 27, 2006 | TE: | RLD: | Yes |
Expired US Patents for NDA 021526
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-002 | Jan 27, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-001 | Feb 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Menarini Intl | RANEXA | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 021526-001 | Feb 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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