Details for New Drug Application (NDA): 216018
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NDA 216018 describes ASPRUZYO SPRINKLE, which is a drug marketed by Spil and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ASPRUZYO SPRINKLE profile page.
The generic ingredient in ASPRUZYO SPRINKLE 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 ASPRUZYO SPRINKLE 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 216018
| Tradename: | ASPRUZYO SPRINKLE |
| Applicant: | Spil |
| Ingredient: | ranolazine |
| Patents: | 2 |
Suppliers and Packaging for NDA: 216018
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ASPRUZYO SPRINKLE | ranolazine | GRANULES, EXTENDED RELEASE;ORAL | 216018 | NDA | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-624 | 47335-624-11 | 1 GRANULE in 1 PACKET (47335-624-11) |
| ASPRUZYO SPRINKLE | ranolazine | GRANULES, EXTENDED RELEASE;ORAL | 216018 | NDA | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-624 | 47335-624-30 | 30 GRANULE in 1 CARTON (47335-624-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULES, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Feb 28, 2022 | TE: | RLD: | Yes | |||||
| Patent: | 11,510,878 | Patent Expiration: | Jan 24, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULES, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
| Approval Date: | Feb 28, 2022 | TE: | RLD: | Yes | |||||
| Patent: | 10,898,444 | Patent Expiration: | Jan 24, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,510,878 | Patent Expiration: | Jan 24, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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