Details for New Drug Application (NDA): 208647
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NDA 208647 describes EZALLOR SPRINKLE, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the EZALLOR SPRINKLE profile page.
The generic ingredient in EZALLOR SPRINKLE is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
The generic ingredient in EZALLOR SPRINKLE is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 208647
| Tradename: | EZALLOR SPRINKLE |
| Applicant: | Sun Pharm |
| Ingredient: | rosuvastatin calcium |
| Patents: | 1 |
Pharmacology for NDA: 208647
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208647
Suppliers and Packaging for NDA: 208647
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EZALLOR SPRINKLE | rosuvastatin calcium | CAPSULE;ORAL | 208647 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-984 | 47335-984-64 | 3 BLISTER PACK in 1 CARTON (47335-984-64) / 10 CAPSULE in 1 BLISTER PACK (47335-984-60) |
| EZALLOR SPRINKLE | rosuvastatin calcium | CAPSULE;ORAL | 208647 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-984 | 47335-984-81 | 90 CAPSULE in 1 BOTTLE (47335-984-81) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Dec 18, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 10,413,543 | Patent Expiration: | Feb 12, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Dec 18, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 10,413,543 | Patent Expiration: | Feb 12, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Dec 18, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 10,413,543 | Patent Expiration: | Feb 12, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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