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DOCKETS
MANAGEMENT |
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Dockets
Entered On July 22, 2003
Table of Contents |
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Docket #
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Title
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1995N-0304 |
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Ephedrine Alkaloids: Reports
of Adverse Events; Availability |
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1996P-0500 |
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Amend "Healthy" Definition
re: Sodium Levels |
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2000D-1538 |
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Electronic Records; Electronic
Signatures, Validation |
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2000D-1539 |
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Electronic Records & Signatures,
Retention of Electronic Rec |
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2000D-1540 |
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Electronic Signatures, Electronic
Copies of Electronic Recor |
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2000D-1541 |
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Electronic Signatures: Audit
Trails |
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2000D-1542 |
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Electronic Signatures: Time
Stamps |
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2000D-1543 |
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Electronic Signatures: Glossary
of Terms |
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2000N-1571 |
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Enrofloxacin for Poultry: Opportunity
for Hearing |
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2002D-0385 |
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Approval of Labeling for Foods
Treated by Irradiation |
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2003N-0017 |
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Risk Management Programs on
the Practice of Pharmacy |
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2003N-0076 |
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Food Labeling: Trans Fatty
Acids in Nutrition Labeling; Consumer research to consider possible
footnote statements |
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2003N-0302 |
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Agency Information Collection
Activities; Proposed Collection; Comment Request; Certain Biologics
Labeling |
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2003N-0311 |
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Agency Information Collection
Activities: Proposed Collection; Comment Request; MDUFMA Small Business
Qualification Certification (Form FDA 3602) |
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2003P-0315
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Doxycycline hyclate tablets
20 mg in which bioequivalence of the Mutual product to CollaGened
Periostat , the reference listed drug |
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Details |
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1995N-0304 |
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Ephedrine Alkaloids: Reports
of Adverse Events; Availability |
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C 4042 |
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Ernest J. Istook, Jr. (CI)
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Vol #: |
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374 |
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C 4043 |
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Ephedra Education Council
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Vol #: |
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374 |
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C 4044 |
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Barry Sherr |
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Vol #: |
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374 |
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EMC 810 |
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Zoesfrogs |
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Vol #: |
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375 |
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EMC 811 |
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Anna P. Morones |
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Vol #: |
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375 |
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EMC 812 |
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Kelly Quellette |
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Vol #: |
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375 |
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EMC 813 |
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Harl & Melba Sims
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Vol #: |
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375 |
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EMC 814 |
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John Diaz (Canada) |
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Vol #: |
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375 |
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EMC 815 |
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Nicolle J. White |
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Vol #: |
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375 |
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EMC 816 |
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number not used |
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Vol #: |
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375 |
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EMC 817 |
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number not used |
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Vol #: |
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375 |
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EMC 818 |
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Mike Sanchez |
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Vol #: |
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375 |
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EMC 819 |
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Joy K. Karschnik |
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Vol #: |
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375 |
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EMC 820 |
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Betty Martini |
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Vol #: |
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375 |
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EMC 3445 |
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Fleur Wiorkowski |
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Vol #: |
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281 |
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EMC 3446 |
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Judith Fish |
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Vol #: |
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281 |
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1999D-4130 |
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Information Disclosure by Manufacturers
to Assemblers for Diagnostic X-ray Systems |
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C 5 |
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Robert Ward |
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Vol #: |
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1 |
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2000D-1538 |
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Electronic Records; Electronic
Signatures, Validation |
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LST 14 |
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Gen. References for Guidance
July 1, 2003 |
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Vol #: |
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0 |
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2000D-1539
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Electronic Records & Signatures,
Retention of Electronic Rec |
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LST 14 |
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Gen. References for Guidance
July 1, 2003 |
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Vol #: |
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9 |
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2000D-1540
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Electronic Signatures, Electronic
Copies of Electronic Recor |
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LST 14 |
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Gen. References for Guidance
July 1, 2003 |
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Vol #: |
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6 |
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2000D-1541
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Electronic Signatures: Audit
Trails |
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LST 14 |
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Gen. References for Guidance
July 1, 2003 |
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Vol #: |
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6 |
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2000D-1542
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Electronic Signatures: Time
Stamps |
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LST 14 |
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Gen. References for Guidance
as of July 1, 2003 |
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Vol #: |
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7 |
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2000D-1543
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Electronic Signatures: Glossary
of Terms |
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LST 14 |
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Updated List of Part 11 Venders
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Vol #: |
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7 |
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2000D-1598 |
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Voluntary Labeling for Bioengineered
Foods |
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C 9998 |
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Ms. Janet Cameron Duffy
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Vol #: |
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580 |
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C 9999 |
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Ms. Shannon Holloway
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Vol #: |
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580 |
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LET 3 |
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Ms. Demelza Costa |
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Vol #: |
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580 |
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2000N-1571
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Enrofloxacin for Poultry: Opportunity
for Hearing |
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BRF 1 |
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Center for Veterinary Medicine
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Vol #: |
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379 |
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BRF 2 |
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Bayer Corporation |
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Vol #: |
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379 |
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BRF 3 |
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Bayer Corporation |
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Vol #: |
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379 |
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2001P-0230 |
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Domestic Marketing & Importation
of Transgenic Fish |
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EMC 2982 |
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Joseph Kalgren |
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Vol #: |
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252 |
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EMC 2983 |
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Christie Jones |
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Vol #: |
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252 |
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EMC 2984 |
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Mike Hargrave |
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Vol #: |
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252 |
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EMC 2985 |
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Priscilla McKillip |
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Vol #: |
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252 |
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EMC 2986 |
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Liz Fuerst |
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Vol #: |
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252 |
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EMC 2987 |
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Anna Jeavons |
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Vol #: |
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252 |
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EMC 2988 |
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Marilyn Magnus |
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Vol #: |
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252 |
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EMC 2989 |
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Joddie Powell |
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Vol #: |
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252 |
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2002D-0385
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Approval of Labeling for Foods
Treated by Irradiation |
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C 16 |
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Guardion |
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Vol #: |
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1 |
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2003N-0017
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Risk Management Programs on
the Practice of Pharmacy |
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N 2 |
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FDA |
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Vol #: |
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1 |
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2003N-0076 |
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Food Labeling: Trans Fatty
Acids in Nutrition Labeling; Consumer research to consider possible
footnote statements |
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NAP 1
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FDA |
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Vol #: |
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1 |
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2003N-0302 |
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Agency Information Collection
Activities; Proposed Collection; Comment Request; Certain Biologics
Labeling |
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N 1 |
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FDA |
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Vol #: |
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1 |
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2003N-0311
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Agency Information Collection
Activities: Proposed Collection; Comment Request; MDUFMA Small
Business Qualification Certification (Form FDA 3602) |
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N 1 |
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FDA |
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Vol #: |
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1 |
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2003P-0315 |
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Doxycycline hyclate tablets
20 mg in which bioequivalence of the Mutual product to CollaGened
Periostat , the reference listed drug |
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ACK 2 |
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HFA-305 to CollaGenex Pharmaceuticals
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Vol #: |
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1 |
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PSA
1 |
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CollaGenex Pharmaceuticals
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Vol #: |
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1 |
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