Details for New Drug Application (NDA): 213517
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NDA 213517 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 Inc, Sun Pharm, Sunshine, Torrent, Unichem, and Vkt Pharma, and is included in twenty-six 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 are twenty-three drug master file entries 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 are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.
Summary for 213517
| Tradename: | RANOLAZINE |
| Applicant: | I3 Pharms |
| Ingredient: | ranolazine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213517
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 213517 | ANDA | Bryant Ranch Prepack | 71335-2556 | 71335-2556-1 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2556-1) |
| RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 213517 | ANDA | i3 Pharmaceuticals, LLC | 72319-021 | 72319-021-02 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 27, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
| Approval Date: | Apr 27, 2022 | TE: | AB | RLD: | No | ||||
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