Details for New Drug Application (NDA): 214551
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NDA 214551 describes RANOLAZINE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Ani Pharms, Arthur Grp, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, I3 Pharms, Jubilant Generics, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Rising, Sciegen Pharms, Sun Pharm, Sunshine, Torrent, Umedica, Unichem, and Vkt Pharma, and is included in twenty-seven NDAs. It is available from twenty-seven suppliers. Additional details are available on the RANOLAZINE profile page.
The generic ingredient in RANOLAZINE is ranolazine. There is one drug master file entry for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
The generic ingredient in RANOLAZINE is ranolazine. There is one drug master file entry for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
Summary for 214551
| Tradename: | RANOLAZINE |
| Applicant: | Umedica |
| Ingredient: | ranolazine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214551
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 214551 | ANDA | Umedica Laboratories USA Inc. | 60290-055 | 60290-055-01 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-055-01) |
| RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 214551 | ANDA | Umedica Laboratories USA Inc. | 60290-055 | 60290-055-03 | 6 BLISTER PACK in 1 CARTON (60290-055-03) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 5, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
| Approval Date: | Aug 5, 2026 | TE: | AB | RLD: | No | ||||
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