APPLICATION INTEGRITY POLICY LIST
Updated: April 05, 2004
The names of the firms listed below are those that were notified that FDA is deferring
substantive scientific review of one or more of the firm's applications and/or is
proceeding to withdraw the approved applications.
The asterisk (*) indicates that, to the agency's knowledge, the firm is out of
business. This table includes the company's Central File Number and identification number
in FDA's electronic Field Accomplishment and Compliance Tracking System (FACTS); or the
FACTS Federal Establishment Identification Number (FEI).
CENTER FOR DRUG EVALUATION AND RESEARCH
| Firm |
Location |
Central File No./FACTS No. |
Remarks |
| Biochimica Opos SpA |
Agrate Brianza, Italy |
9611856/3002806473 |
|
| Biopharmaceutics Inc.* |
Bellport, NY |
2434267/2434267 |
|
| Solopak Pharmaceuticals, Inc. |
1. Elk Grove Village, IL |
1. 51450942 (Tonne Rd.)/1450942 and 51423737
(Chase St.)/3000719798 |
|
| 2. Franklin Park, IL |
2. 51419209/1419209 |
| Superpharm Corp.* |
Bayshore, NY |
2434256/2434256 |
|
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
| Firm |
Location |
Central File No./FACTS No. |
Remarks |
| Sclavo, S.p.a.* |
Siena, Italy |
9610932/1000300459 |
|
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
| Firm |
Location |
Central File No./FACTS No. |
Remarks |
| AGA Medical Corporation |
682 Mendelssohn Ave. N
Golden Valley, MN |
FEI: 3000927285 |
Letter Dated: December
12, 2003 |
| Bionike, Inc. |
South San Francisco, CA |
No CFN/1000162526 |
|
| Bioplasty, Inc.* |
Minneapolis, MN |
B2125840/2125840 |
|
| Diagnostic Products Corporation |
5700 West 96th Street
Los Angeles, CA |
FEI: 2017183 |
Letter Dated:
February
24, 2004 |
| Endotec, Inc. |
South Orange, NJ |
FEI: 3002400750 |
|
| Micro Detect, Inc. |
Tustin, CA |
FEI: 3001697474 |
|
| PLUS Orthopedics |
San Diego, CA |
FEI: 3001237832 |
Letter Dated: March
30, 2004 |
| Sherman Pharmaceutical, Inc.* |
Abita Springs, LA |
2310787/2310787 |
|
| Syntron |
Carlsbad, CA |
2025760/96782 |
|
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
None
CENTER FOR VETERINARY MEDICINE
None |
