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| Dockets Entered
On February 1, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| 2004E-0314
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| Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005P-0319
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| Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets
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| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| 2005P-0406
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| Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
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| 2005P-0407
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| ANDA for Efavirenz Tablets for Oral Suspension 50 mg, 100 mg and 200 mg
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| 2005P-0408
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| Amend 21CFR101.5, Food; name and place of business of manufacturer, packer, or distributor
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 2006P-0060
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| ANADA for Unibute Granules 200 mg phenylbutazone per g of of granules instant of paste
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
17246
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| Beulah Land Corporation
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| Vol #:
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| 158
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| LET
17247
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| Beulah Land Corporation
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| Vol #:
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| 158
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| LET
17248
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| Beulah Land Corporation
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| Vol #:
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| 158
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| LET
17249
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| Beulah Land Corporation
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| Vol #:
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| 158
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| LET
17250
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| Beulah Land Corporation
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| Vol #:
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| 158
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| LET
17251
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| Beulah Land Corporation
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| Vol #:
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| 158
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| LET
17252
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| Beulah Land Corporation
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| Vol #:
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| 158
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| LET
17253
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| Enzymatic Therapy
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| Vol #:
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| 158
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| EC
3
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| Mr. owen meany
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| Vol #:
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| 1
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| EC
4
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| Mr. Owen Meany
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| Vol #:
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| 1
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| EC
5
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| California State Legislature
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| Vol #:
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| 1
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| EC
6
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| Family Tree Clinic
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| Vol #:
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| 1
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| EC
7
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| Mr. owen meany
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| Vol #:
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| 1
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| EC
8
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| stopN9condoms.com
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| Vol #:
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| 1
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| EMC 94
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| Form Letter
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| Vol #:
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| 9
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| C 1
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| S. Tumbarello
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| Vol #:
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| 1
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| C
2
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| Siegmyer, Oshman & Geddie, LLP
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| Vol #:
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| 1
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| C 3
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| E. Jackson
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| Vol #:
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| 1
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| EC
11
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| Planned Parenthood Federation of America
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| Vol #:
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| 1
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| EC
12
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| Hybridfour
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| Vol #:
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| 1
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| EC
13
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| Academy of Medicine of Cleveland/Northern Ohio
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| Vol #:
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| 6
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| EC
14
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| Eli Lilly and Company
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| Vol #:
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| 6
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| EC
15
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| National Consumers League
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| Vol #:
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| 6
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| EC
16
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| Plain Language Network
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| Vol #:
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| 6
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| EC
17
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| Center for Plain Language
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| Vol #:
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| 6
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| EC
18
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| U.S. Department of Health and Human Services
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| Vol #:
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| 6
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| EC
19
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| American Society of Health-System Pharmacists
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| Vol #:
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| 6
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| EC
4
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| Burdock Group
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| Vol #:
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| 4
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| EC
5
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| Women's Health Sciences Institute
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| Vol #:
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| 4
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| EC
6
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| National Nutritional Foods Association
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| Vol #:
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| 4
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| EC
7
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| Kraft Foods Global, Inc.
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| Vol #:
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| 4
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| EC
8
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| Grocery Manufacturers Association
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| Vol #:
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| 4
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| EC
9
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| International Dairy Foods Association
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| Vol #:
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| 4
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| EC
10
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| American Dietetic Association
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| Vol #:
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| 4
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| 2005P-0319
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| Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets
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| EC
3
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
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| EC
4
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| Ms. Kristi Bothe
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| Vol #:
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| 2
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| EC
2
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2005P-0406
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| Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
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| EC
1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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