Details for New Drug Application (NDA): 208647
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The generic ingredient in EZALLOR SPRINKLE is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Forty-four 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 |
Formulation / Manufacturing: | see details |
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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Feb 12, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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