Details for New Drug Application (NDA): 210188
✉ Email this page to a colleague
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 210188
Tradename: | RANOLAZINE |
Applicant: | Cadila |
Ingredient: | ranolazine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210188
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 210188 | ANDA | Zydus Lifesciences Limited | 70771-1499 | 70771-1499-1 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1499-1) |
RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 210188 | ANDA | Zydus Lifesciences Limited | 70771-1499 | 70771-1499-4 | 10 BLISTER PACK in 1 CARTON (70771-1499-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1499-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No |
Complete Access Available with Subscription