NDA/ BLA #

Application Received Date

Action Taken

Center

Office

Division/ Office

Standard/ Priority

PMRs/ PMCs

AC Meeting

Included Timelines in Filing Communication

Met Target Date

22288

11/12/08

Approval

CDER

OAP

DAIOP

S

N

Y

Y

Did Not Meet

22408

1/22/09

CR***

CDER

ODEIII

DDDP

S

N

**

Y

Pending

22393

1/12/09

Approval

CDER

OODP

DDOP

S

Y

Y

Y

Pending

22465

12/19/08

Approval

CDER

OODP

DDOP

S

Y

Y

N*

N/A

22562

6/18/09

Approval

CDER

ODEIII

DGP

P

Y

Y

N*

N/A

22363

10/3/08

Approval

CDER

ODEII

DMEP

S

Y

N

N

N/A

22505

5/29/09

Pending***

CDER

ODEII

DMEP

S

N

**

Y

Pending

22454

3/9/09

CR***

CDER

ODEIV

DMIP

P

N

Y

Y

Did Not Meet

22399

1/9/09

CR***

CDER

ODEI

DNP

S

N

**

Y

Pending

22522

7/17/09

CR***

CDER

ODEII

DPARP

S

N

**

Y

Pending

125293

10/31/08

CR***

CDER

ODEII

DPARP

P

Y

Y

Y

Did Not Meet

125319

12/17/08

Approval

CDER

ODEII

DPARP

P

Y

**

N

N/A

125338

2/27/09

Approval

CDER

ODEII

DPARP

P

Y

Y

Y

Did Not Meet

22252

7/6/09

Approval

CDER

ODEIII

DRUP

S

Y

N

Y

Pending

125320

12/19/08

CR***

CDER

ODEIII

DRUP

S

N

**

Y

Pending

125350

4/30/09

Approval

CBER

OBRR

OBRR

S

Y

N

Y

Did Not Meet

125347

3/17/09

Approval

CBER

OVRR

OVRR

P

Y

N

Y

Met Timeline

125324

3/31/09

Approval

CBER

OVRR

OVRR

P

Y

**

Y

Unsolicited Amendments

125351

6/5/09

Approval

CBER

OBRR

OBRR

S

Y

N

Y

Met Timeline

*Information was redacted from the applications below to protect confidentiality.

CR

P

N

**

Y

Pending

CR

S

N

N

Y

Did Not Meet

CR

S

N

**

N*

N/A

Withdrawn

S

N

**

Y

Pending

CR

S

N

**

Y

Pending

CR

S

N

N

Y

Met Timeline

CR

S

N

**

N

N/A

CR

S

N

Y

Y

Did Not Meet

CR

S

N

**

Y

Pending

CR

S

N

**

Y

Pending

CR

S

N

**

Y

Pending

CR

P

N

N

Y

Met Timeline

CR

P

N

**

Y

Unsolicited Amendments

CR

S

N

Y

Y

Did Not Meet

CR

P

N

**

Y

Pending

CR

S

N

N

Y

Did Not Meet

CR

S

N

**

Y

Pending