APPLICATION INTEGRITY POLICY LISTUpdated: April 10, 2003 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 BIOLOGICAL 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 |
|---|
| Bionike, Inc. | South San Francisco, CA | No CFN/1000162526 | Looking for more exclusive Biotech Information? |  | In addition to our free knowledge base, BiotechWatch provides the following additional services: - Premium Database, for in-depth coverage of biotechnology companies in the sector, giving the user the ability to search and sort based on more than twenty parameters.
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| | 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 |
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CENTER FOR FOOD SAFETY AND APPLIED NUTRITIONNone CENTER FOR VETERINARY MEDICINE None |
