Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on November 27, 2000

TABLE OF CONTENTS

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76N-052H OTC Antihistamine Drug Products *
78N-0301 OTC External Analgesic Drug Products *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
97N-0289 Pregnancy Labeling; Content & Format Requirements *
97N-0314 Prescription Drug Products; Levothyroxine Sodium *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
00D-1392 Guidance for Industry on Botanical Drug Products *
00D-1424 Analytical procedures and methods validation; drug substance *
00N-1367 Postmarket Surveillance *
00N-1409 Revision of the Identification of the Ionotophoresis *
00P-0498 Exempt Swan-Ganz Pacing Catheters and Probes *
00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20 *
00P-0913 ANDA suitability for Albuterol Sulfate inhalation solution, *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m *
00P-1472 Over-the-counter sodium phosphate bowel preparation products *
00P-1499 Remove alosetron (Lotronex) from the market *
00P-1556 Policy regarding ANDA holder confidentiality *
00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt *
76N-052H OTC Antihistamine Drug Products

C 231 CHPA Vol#: 39


78N-0301 OTC External Analgesic Drug Products

MT 10 HFD-560 & Chattem Inc Vol#: 99


95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 83 Ryan S Cornell Vol#: 5

97N-0289 Pregnancy Labeling; Content & Format Requirements

SUP 2 Rosario Zisa CPA Vol#: 6


97N-0314 Prescription Drug Products; Levothyroxine Sodium

ACK 2 HFA-305 Vol#: 1

CP 4 Jerome Stevens Pharmaceuticals Inc Vol#: 1


99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

C 8 Women's Community cancer Project Vol#: 3


00D-1392 Guidance for Industry on Botanical Drug Products

C 23 National Research Institute of Chinese M Vol#: 2

00D-1424 Analytical procedures and methods validation; drug substance

C 4 Emisphere Technologies Inc Vol#: 1

C 5 HEli Lilly and Company Vol#: 1

C 6 GlaxoWellcome Research & Development Vol#: 1

C 7 Baxter Healthcare Corporation Vol#: 1

C 8 Calibration & Validation Group Vol#: 1

SUP 1 SmithKline Beechman Pharmaceuticals Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

ANS 3 HFS-1 to Council for Responsible Nutriti Vol#: 78

ANS 4 HFS-1 to ACitizens for Health Vol#: 78

C 39 Council for Responsible Nutrition Vol#: 78

EMC 21 Moldydude Vol#: 78

EMC 22 Eric Potratz Vol#: 78

EXT 8 Citizens for Health Vol#: 78

LET 10 HFS-1 to Council for Responsible Nutriti Vol#: 78

SUP 1 Ephedra Education Council Vol#: 78

00N-1367 Postmarket Surveillance

C 1 Cook Group Inc Vol#: 1

C 2 Advanced medical Technology Association Vol#: 1


00N-1409 Revision of the Identification of the Ionotophoresis

C 2 Cystic Fibrosis Foundation Vol#: 1


00P-0498 Exempt Swan-Ganz Pacing Catheters and Probes

EXP 2 Edwards Vol#: 1


00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20

PDN 1 HFD-1 to Lord Bissell & Brook (Apotex In Vol#: 1


00P-0913 ANDA suitability for Albuterol Sulfate inhalation solution,

C 1 Dey LP Vol#: 1


00P-1210 Restrict Sale of Coal Tar-Containing Products

SUP 1 State of California Dept. of Justice Vol#: 1


00P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m

C 1 Pfizer Inc Vol#: 1


00P-1472 Over-the-counter sodium phosphate bowel preparation products

RC 1 C B Fleet Company Inc Vol#: 2


00P-1499 Remove alosetron (Lotronex) from the market

EMC 38 University Louisville School of Medicine Vol#: 1


00P-1556 Policy regarding ANDA holder confidentiality

C 1 National Association of Pharmaceutical M Vol#: 1


00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt

SUP 2 New Jersey General Assembly Vol#: 1

00P-1603 Rescind Any Contraindications For Use of Misoprostol In Preg

C 1 Form Letter 3 Vol#: 2