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Orange Book product · Generic (ANDA)

ROSUVASTATIN CALCIUM

ROSUVASTATIN CALCIUM

Generic (ANDA)ANDA 207408TE ABRX CHANGZHOU PHARM
View ROSUVASTATIN CALCIUM familyOpen on FDA Orange Book

At a glance

Oct 31, 2016

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 31, 2016

    9 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ROSUVASTATIN CALCIUM

Strength

EQ 5MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 207408

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ROSUVASTATIN CALCIUM

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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