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Last Updated: January 17, 2021

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Details for New Drug Application (NDA): 208647

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NDA 208647 describes EZALLOR SPRINKLE, which is a drug marketed by Sun Pharma Global 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.
Summary for 208647
Tradename:EZALLOR SPRINKLE
Applicant:Sun Pharma Global
Ingredient:rosuvastatin calcium
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 208647
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:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Dec 18, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 12, 2036Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Dec 18, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 12, 2036Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Dec 18, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 12, 2036Product Flag?YSubstance Flag?Delist Request?

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