Orange Book product · Brand (NDA)

EZALLOR SPRINKLE

ROSUVASTATIN CALCIUM

Brand (NDA)NDA 208647DISCN SUN PHARM

Dec 18, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 18, 2018
7 yr 7 mo ago
Today
Patent 10413543 expires
Listed drug product patent expiration.
Feb 12, 2036
in 9 yr 10 mo

Active ingredient

ROSUVASTATIN CALCIUM

Strength

EQ 5MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 208647

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10413543	Feb 12, 2036	in 9 yr 10 mo	Product