Approval of Crestor, Nda #021366 (Labeling)

Download Drugs@FDA Express for free

Search by Drug Name, Active Ingredient, or Application Number*

Enter at least 3 characters

Browse by Drug Name

A  

B  

C  

D  

E  

F  

G  

H  

I  

J  

K  

L  

M  

N  

O  

P  

Q  

R  

S  

T  

U  

V  

W  

X  

Y  

Z  

  0-9

Drug Approval Reports by Month

Select a Report:

Reports include only BLAs/NDAs/ANDAs or supplements to those applications approved by the Center for Drug Evaluation and Research (CDER) and tentative NDA/ANDA approvals in CDER. The reports do not include applications or supplements approved by the

All Approvals and Tentative Approvals by Month
Approvals of New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs), and supplements to those applications; and tentative approvals of ANDAs and NDAs.

Reports include only BLAs/NDAs/ANDAs or supplements to those applications approved by the Center for Drug Evaluation and Research (CDER) and tentative NDA/ANDA approvals in CDER. The reports do not include applications or supplements approved by the Center for Biologics Evaluation and Research (CBER)

Original NDA and Original BLA Approvals by Month

NDAs and BLAs approved for the first time during the selected month

Original ANDA Approvals by Month

Original ANDA approvals (applications for generic drugs)

Supplemental Approvals to NDAs and BLAs by Month

Supplemental approvals to NDAs and BLAs

Tentative ANDA Approvals by Month

Tentatively approved applications for generic drugs

Select a month and year

Month:

Year:

* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). For prescription brand-name drugs, Drugs@FDA typically includes the most recent labeling approved by the FDA (for example, Prescribing Information and FDA-approved patient labeling when available), regulatory information, and FDA staff reviews that evaluate the safety and effectiveness of the drug.