2004P-0127 ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161) 2004P-0128 ANADA for clavamox (amoxicillin trihydrate/clavulanate potassium) tablets for dogs and cats 2004Q-0097 Qualified Health Claim: Calcium and various cancers 2004Q-0098 Qualified Health Claim: Calcium and hypertension 2004Q-0099 Qualified Health Claim: Calcium and menstrual disorders 2004Q-0100 Qualified Health Claim: Calcium and bone fractures
2004Q-0102 Qualified Health Claim: Calcium and Kidney/urinary stones
1993N-0480O Health Claims; Omega-3 Fatty Acids & CHD
MT 1 HFS-832 to Emord & Associates, PC Vol #: 1
1993N-0480Z Health Claims for Zinc & Immune Deficiency in Elderly
MT 1 HFS-832 to Emord & Associates, PC Vol #: 1
1997P-0197 Require that warning labels about risks of salmonella enteri
C 829
Signatures
Center for Science in the Public Interest (CSPI) Vol #: 30
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 13258 pH Sciences Vol #: 109
LET 13259 pH Sciences Vol #: 109
LET 13260 Natrol, Inc. Vol #: 109
LET 13261 Body Wise International, Inc. Vol #: 109
LET 13262 Body Wise International, Inc. Vol #: 109
LET 13263 Body Wise International, Inc. Vol #: 109
LET 13264 Body Wise International, Inc. Vol #: 109
LET 13265 FreeLife LLC Vol #: 109
LET 13266 Source Naturals Vol #: 109
LET 13267 Life Source, Inc. Vol #: 109
LET 13268 Life Source, Inc. Vol #: 109
LET 13269 Life Source, Inc. Vol #: 109
LET 13270 Life Source, Inc. Vol #: 109
LET 13271 Enzymatic Therapy Natural Medicines Vol #: 109
LET 13272 NEK Products, Inc. Vol #: 109
LET 13273 Body Wise International, Inc. Vol #: 109
LET 13274 Body Wise International, Inc. Vol #: 109
LET 13275 Ortho Molecular Products, Inc. Vol #: 109
LET 13276 Body Wise International, Inc. Vol #: 109
LET 13277 Body Wise International, Inc. Vol #: 109
LET 13278 Body Wise International, Inc. Vol #: 109
LET 13279 Alva-Amco Pharmacal Companies, Inc. Vol #: 109
LET 13280 Supernatural Health, Inc. Vol #: 109
LET 13281 MuscleTech Research and Development, Inc. Vol #: 109
LET 13282 Optimum Nutrition Vol #: 109
LET 13283 Lane Labs USA, Inc. Vol #: 109
LET 13284 Lidtke Technologies Vol #: 109
LET 13285 Perrigo Company of South Carolina Vol #: 109
LET 13286 Perrigo Company of South Carolina Vol #: 109
LET 13287 Shaklee Corporation Vol #: 109
LET 13288 Shaklee Corporation Vol #: 109
LET 13289 Nature's Answer Inc. Vol #: 109
LET 13290 Metagenics Inc. Vol #: 109
LET 13291 Leiner Health Prorducts Vol #: 109
LET 13292 Enzymatic Therapy Natural Medicines Vol #: 109
1998P-0504 Raw Molluscan Shellfish of Undetectable Levels
C 269
Signatures
Center for Science in the Public Interest (CSPI) Vol #: 18
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 18224 D. Shively Vol #: 516
1999P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease
MT 1 HFS-832 to Emord & Associates, PC Vol #: 13
1999P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O
C 5 Omega Protein Corporation Vol #: 1
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
CS 48 HFA-305 Vol #: 389
IDF 1 HF-3 Vol #: 389
2000P-1322 Food Labeling and Allergen Contamination Control
C 543 R. Jasinski, MD Vol #: 30
LET 5 Center for Science in the Public Interest (CSPI) Vol #: 30
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 367 B. Calhoun,MD,FACOG,FACS Vol #: 162
EMC 4533 E. H Reiss Vol #: 169
EMC 4534 M. Ball Vol #: 169
EMC 4535 K A Schuck Vol #: 169
EMC 4536 D. Dixon Vol #: 169
EMC 4537 M. Kirwin Vol #: 169
EMC 4538 T. St. Clair Vol #: 169
EMC 4539 L. Pearson Vol #: 169
EMC 4540 M. Morgan Vol #: 169
EMC 4541 R. Michaels Vol #: 169
EMC 4542 J. Pasiuk Vol #: 169
EMC 4543 G. Beason Vol #: 169
EMC 4544 B. Jastromb Vol #: 169
EMC 4545 M. Giresi Vol #: 169
EMC 4546 K. Baker Vol #: 169
EMC 4547 J. Thomas Vol #: 169
EMC 4548 R. E. Dritz Vol #: 169
EMC 4549 O. Z. White Vol #: 169
EMC 4550 S. Farrington Vol #: 169
EMC 4551 J. Meyer Vol #: 169
EMC 4552 A. Richards Vol #: 169
EMC 4553 D. J. Goldberg Vol #: 169
EMC 4554 K. Fine Vol #: 169
EMC 4555 E. Beaven Vol #: 169
EMC 4556 M. Gannon Vol #: 169
EMC 4557 J. Wilson Vol #: 169
EMC 4558 C. Normand Vol #: 169
EMC 4559 S. Johnston Vol #: 169
EMC 4560 C. Kilgore-Hadley Vol #: 169
EMC 4561 L. Mann Vol #: 169
EMC 4562 K. Forrette Vol #: 169
EMC 4563 F. Williams Vol #: 169
EMC 4564 B. Ercoline Vol #: 169
EMC 4565 E. Watkins Vol #: 169
EMC 4566 M. Easter-Dawson Vol #: 169
EMC 4567 N. Zeidan Vol #: 169
EMC 4568 L. Sawyer Vol #: 169
EMC 4569 T. A. Smagola Vol #: 169
EMC 4570 J. Diamond Vol #: 169
EMC 4571 D. L. Binkele Vol #: 169
EMC 4572 R. Palm Vol #: 169
EMC 4573 M. Wozniak Vol #: 169
EMC 4574 C. Garcia Vol #: 169
EMC 4575 S. Repan Vol #: 169
EMC 4576 J. Michel Vol #: 169
EMC 4577 E. Walrack Vol #: 169
EMC 4578 C. Moore Vol #: 169
EMC 4579 Dr. R. A. Fischer Vol #: 169
EMC 4580 J. Thomas Vol #: 169
EMC 4581 A. Strickland Vol #: 169
EMC 4582 S. Kaufman Vol #: 169
EMC 4583 H. Z. Spagna Vol #: 169
EMC 4584 A. Robinson Vol #: 169
EMC 4585 A. Kellgren Vol #: 169
EMC 4586 D. McElroy Vol #: 169
EMC 4587 C. Woodworth Vol #: 169
EMC 4588 E. Smolinski Vol #: 169
EMC 4589 J. Kowal Vol #: 169
EMC 4590 K. Hetrick Vol #: 169
EMC 4591 R. Kowal Vol #: 169
EMC 4592 K. O'Connor Vol #: 169
EMC 4593 G. Linx Vol #: 169
EMC 4594 A. Kilzer Vol #: 169
EMC 4595 R. Clouser Vol #: 169
EMC 4596 J. J. Tuinstra Vol #: 169
EMC 4597 G. Ortiz Vol #: 169
EMC 4598 N. C. Westfall Vol #: 169
EMC 4599 P. De Moor Vol #: 169
EMC 4600 B. Peterson Vol #: 169
EMC 4601 P. Palmer Vol #: 169
EMC 4602 M. Agee Vol #: 169
EMC 4603 L. M. lamerand Vol #: 169
EMC 4604 M. Adrian Vol #: 169
EMC 4605 B. Flores Vol #: 169
EMC 4606 M.Masi Vol #: 169
EMC 4607 D. Brown Vol #: 169
EMC 4608 M. Lipow Vol #: 169
EMC 4609 J. Gharibian Vol #: 169
EMC 4610 F. Thomas Vol #: 169
EMC 4611 D. Jones Vol #: 169
EMC 4612 R. Lanza Vol #: 169
EMC 4613 V. Rivers Vol #: 169
EMC 4614 A. McKune Vol #: 169
EMC 4615 L. Friedman Vol #: 169
EMC 4616 C. Aken Vol #: 169
EMC 4617 B. Zdrojewski Vol #: 169
EMC 4618 A. Avilie Vol #: 169
EMC 4619 P. Koteles Vol #: 169
EMC 4620 V. A. Lavin Vol #: 169
EMC 4621 K. Coughlan Vol #: 169
EMC 4622 B. E. Young Vol #: 169
EMC 4623 M. Martin Vol #: 169
EMC 4624 P. C. Rogers Vol #: 169
EMC 4625 A. Griffin Vol #: 169
2002N-0277 Bioterrorism; Establishment & Maintenance of Records
REF 1 OMB Review May 9, 2003 Vol #: 17
2002P-0292 Health Claims: Walnuts & Cornary Disease
LET 10 HFS-200 to Covington & Burling Vol #: 6
2003D-0522 Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
C 10 J. Baker Vol #: 1
C 11 Illegible Vol #: 1
2003D-0570 Draft on the Clinical Evaluation of Weight-Control Drugs
C 1 American Obesity Assn (AOA) Vol #: 1
2003E-0406 Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
N 1 FDA Vol #: 1
2003E-0411 Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262
N 1 FDA Vol #: 1
2003E-0416 Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
N 1 FDA Vol #: 1
2003E-0448 Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
N 1 FDA Vol #: 1
2003E-0449 Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
N 1 FDA Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
C 14 J. Olsen, RD Vol #: 3
C 15 M. Rosen Vol #: 1
C 16 S. Nally Vol #: 3
C 17 M. Slining Vol #: 3
2003N-0170 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; AvailabilityACTION: Notice of availability.
NAD 1 FDA Vol #: 1
2003P-0126 Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
LET 3 Hogan & Hartson, LLP Vol #: 1
2003P-0276 Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
C 2
Signatures
Cneter for Science in the Public Interest (CSPI) Vol #: 1
2003P-0387 Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
LET 3 Hogan & Hartson, LLP Vol #: 3
2003P-0393 Diazepam Injection USP, 5 mg/mL, 1-mL,(ANDA No. 72-079), by Abbott laboratories, Inc., has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
N 1 FDA Vol #: 1
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
C 1 G. McClary Vol #: 1
C 2 L and D McDowell Vol #: 1
C 3 No signature Vol #: 1
C 4 D. DuBois Vol #: 1
C 5 J. Dunn, Jr. Vol #: 1
C 6 M. Klein, MD Vol #: 1
C 7 E. Koch Vol #: 1
C 8 D. Schoen Vol #: 1
C 9 A. Pennignton Vol #: 1
C 10 F. Smith Vol #: 1
C 11 P. Burton Vol #: 1
C 12 T. Torblch, Jr. Vol #: 1
C 13 E. Petroske Vol #: 1
C 14 P. Press Vol #: 1
C 15 H. Schiffman Vol #: 1
C 16 I. Segalman Vol #: 1
C 17 M. Schoenbrun Vol #: 1
C 18 Form Letters Vol #: 2
C 19 Form Letters Vol #: 3
2004D-0028 Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
C 11 S. Alcorn Vol #: 1
C 12 J. Fritz Vol #: 1
C 13 H. Cipolle Vol #: 1
C 14 R. Austin Vol #: 1
C 15 D. Moore Vol #: 1
C 16 L. Keir Vol #: 1
C 17 P. Leslie Vol #: 1
C 18 G. Powers Vol #: 1
C 19 S. Roh Vol #: 1
C 20 K. Brady Vol #: 1
C 21 J. Mcachaughton Vol #: 1
C 22 EB Meade Vol #: 1
C 23 M. Hartell Vol #: 1
C 24 M. Naoll Vol #: 1
C 25 L. Gray Vol #: 1
C 26 A. Yule Vol #: 1
2004N-0033 Factor VIII Inhibitors
C 1 Wyeth Pharmaceuticals Vol #: 4
2004N-0049 Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
C 1 J. Korsmo Vol #: 1
2004P-0003 Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
LET 1 Billy G. Pierson Vol #: 1
2004P-0127 ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
ACK 1 HFA-305 to Smart Drug Systems, Inc. Vol #: 1
CP 1
Generic Label
Pioneer Label
Smart Drug Systems, Inc. Vol #: 1
2004P-0128 ANADA for clavamox (amoxicillin trihydrate/clavulanate potassium) tablets for dogs and cats
ACK 1 HFA-305 to Smart Drug Systems, Inc. Vol #: 1
CP 1
Tab 1, Tab 2
Smart Drug Systems, Inc. Vol #: 1
2004Q-0097 Qualified Health Claim: Calcium and various cancers
ACK 1 HFS-255 to Emord & Associate PC Vol #: 15
LET 1 HFS-800 to Emord & Associate PC Vol #: 15
LET 2 Marine Bio USA Inc Vol #: 15
QHC 1
Exhibit 1, 2-6
Marine Bio USA Inc Vol #: 1
SUP 1
References
Marine Bio USA Inc Vol #: 16
2004Q-0098 Qualified Health Claim: Calcium and hypertension
ACK 1 HFS-830 to Marine Bio USA Inc Vol #: 9
LET 1 HFS-800 to Marine Bio USA Inc Vol #: 9
LET 2 Marine Bio USA Inc Vol #: 9
LET 3 Marine Bio USA Inc Vol #: 9
LET 4 Marine Bio USA Inc Vol #: 9
QHC 1
Exhibit 1, 2-7
Marine Bio USA Inc Vol #: 1
SUP 1
References
Marine Bio USA Inc Vol #: 10
2004Q-0099 Qualified Health Claim: Calcium and menstrual disorders
ACK 1 HFS-830 to Emord & Associates Inc Vol #: 4
LET 1 HFS-800 to Emord & Associates Vol #: 4
LET 2 Marine Bio USA Inc Vol #: 4
QHC 1
Exhibit 1, 2-7
Marine Bio USA, Inc Vol #: 1
SUP 1
References
Marine Bio USA Inc Vol #: 5
2004Q-0100 Qualified Health Claim: Calcium and bone fractures
ACK 1 HFS-830 to Emord & Associats Inc Vol #: 6
LET 1 HFS-800 to Emord & Associates, PC Vol #: 6
LET 2 Marine Bio USA Inc Vol #: 6
QHC 1
Exhibit 1, 2-5
Marine Bio USA, Inc Vol #: 2
SUP 1
References
Marine Bio USA Inc Vol #: 7
2004Q-0102 Qualified Health Claim: Calcium and Kidney/urinary stones
ACK 1 HFS-830 to Emord & Associates, PC Vol #: 6
LET 1 HFS-800 to Emord & Associates, PC Vol #: 6
LET 2 Marine Bio USA Inc Vol #: 6
QHC 1
Exhibit 1, 2-5
Marine Bio USA, Inc Vol #: 1

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Page updated on March 24, 2004 jb

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