Details for New Drug Application (NDA): 207690
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The generic ingredient in RANOLAZINE 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 207690
Tradename: | RANOLAZINE |
Applicant: | Amneal |
Ingredient: | ranolazine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207690
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 207690 | ANDA | Amneal Pharmaceuticals LLC | 65162-376 | 65162-376-06 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-376-06) |
RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 207690 | ANDA | Amneal Pharmaceuticals LLC | 65162-376 | 65162-376-18 | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-376-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Mar 11, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
Approval Date: | Mar 11, 2021 | TE: | RLD: | No |
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