APPLICATION INTEGRITY POLICY LIST
Updated: 2007-09-14
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 |
| 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 |
| Applied Biotech, Incorporated |
San Diego, CA 92121-2901 |
2028231/436412 |
|
| Bionike,
Inc. |
South San Francisco, CA |
No CFN/1000162526
|
|
| Bioplasty, Inc.* |
Minneapolis, MN |
B2125840/2125840 |
|
| Endotec,
Inc. |
South Orange, NJ |
FEI: 3002400750 |
|
| Micro Detect,
Inc. |
Tustin, CA |
FEI: 3001697474 |
|
| 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 |
