DOCKETS ENTERED on 03/06/00

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]

DOCKETS ENTERED on 03/06/00

Table of Contents

(Hyper links are part of the Docket title - not all dockets/documents are linked)

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88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
96P-0215 Withdrawal Norplant's approval for sale in the United States *
98D-1195 Bioanalytical Methods Validation for Human Studies *
99D-3082 E10- Choice of Control Group in Clinical Trials *
99D-4809 Applications Covered by Section 505(b)(2) *
99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat *
99D-5199 Resorbable Adhesion Barrier Devices*
99P-4613 Revoke the Regulation That Approved Posilac *
99P-4648 Grated Parmesan Cheese Deviating from Identity Standards *
99P-5106 Identify Sources of Natural Flavorings*
99P-5317 Stay of Approval of ANDA for a Generic Version of Enalapril *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-0913 ANDA suitability for Albuterol Sulfate inhalation solution, *

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

OB 7 Abbott Laboratories Vol#: 2

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

OB 2 Abbott Laboratories Vol#: 3

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 1870 Theodora Tarbet Vol#: 51

C 1871 Barbara D. Ottaviani Vol#: 51

C 1872 Jean Scott Vol#: 51

C 1873 Paul G. Felice Vol#: 51

C 1874 Carole Cowell Vol#: 51

C 1875 Linda M. Estep Vol#: 51

C 1876 Dr. Dennis O. Bernard & C N. Bernard Vol#: 51

C 1877 Lois E. Babbitt Vol#: 51

C 1878 Gloria S. Keebel Vol#: 51

C 1879 Eunice Hawran Vol#: 51

C 1880 Marilyn S. Summers Vol#: 51

C 1881 Lyndall Parsons Vol#: 51

C 1882 Ron & Michele Scheck Vol#: 51

C 1883 Lois M. Meyer Vol#: 51

C 1884 Anita Hoye Vol#: 51

C 1885 Harold Eisenberg Vol#: 51

C 1886 Terry C. Hall Vol#: 51

C 1887 Gertrude Edzant Vol#: 51

C 1888 Elizabeth Holmes Vol#: 51

C 1889 Kathryn Pinney Vol#: 51

C 1890 Dorothy Guidici Vol#: 51

C 1891 Lavern-Linda Isley Vol#: 51

C 1892 Marty Dould Vol#: 51

C 1893 Donald A. Brandon Vol#: 51

C 1894 Ruth L. Schafer Vol#: 51

C 1895 Barney & Ruth Ann Bassett Vol#: 51

C 1896 Ann H. Kelly Vol#: 51

C 1897 Arthur E. Hasse Vol#: 51

C 1898 Richard Tuott Vol#: 51

C 1899 Barbara H. Barratt Vol#: 51

C 1900 Mary L. Wilton Vol#: 51

C 1901 H. Barnett Vol#: 51

C 1902 Christina Grabill Vol#: 51

C 1903 Ardine Hausch Vol#: 51

C 1904 Janice M. Gammage Vol#: 51

C 1905 Jean Deboer Vol#: 51

C 1906 Ron Dolenia Vol#: 51

C 1907 Denise R. Brown Vol#: 51

C 1908 Helen Black Vol#: 51

C 1909 R. M. Stonecipher Vol#: 51

C 1910 J. Lamb Vol#: 51

C 1911 Charles S. Faulkner Vol#: 51

C 1912 Joyce Tubbe Vol#: 51

C 1913 Charles Demetriades Vol#: 51

C 1914 Larry Bursch Vol#: 51

C 1915 Sharon P. Pichett Vol#: 51

C 1916 Joanne & John Tengelsen Vol#: 51

C 1917 Franklin B. Clark Vol#: 51

C 1918 Lynne D. Bloom Vol#: 51

C 1919 Lilyan Celata Vol#: 51

C 1920 Debbie McNiel Vol#: 51

C 1921 Mary E. Wilson Vol#: 51

C 1922 Thelma Farmer Vol#: 51

C 1923 Federasi Asosiasi Minyak Dan Lemak Nabai Vol#: 51

C 1924 Paya Pinang Group P.T.P.D. HasjratTjipta Vol#: 51

C 1925 Dapartemen Pendidikan Dan Kebudayaan Vol#: 51

C 1926 P.T. P.D. Paya Pinang Vol#: 51

C 1927 P.T. Sumber Sawit Makmur Vol#: 51

C 1928 P.T.Perkebunan Nusantara V Vol#: 51

C 1929 P.T.Tjipta Makmur Vol#: 51

C 1930 Chickasha Cotton Oil Company Vol#: 51

C 1931 Shirley J. Thiele Vol#: 51

C 1932 R. G. Mitchell Vol#: 51

C 1933 Linda N. Sutig Vol#: 51

C 1934 Ann Jones Vol#: 51

C 1935 Janice Baker Vol#: 51

C 1936 Steven Hovatt Vol#: 51

C 1937 Robert M. Brand Vol#: 51

C 1938 Joan Cunningham Vol#: 51

C 1939 Florence Olivenbaum Vol#: 51

C 1940 Marilyn Leve Vol#: 51

C 1941 E & E Dion Vol#: 51

C 1942 Wally & Anna Weiss Vol#: 51

C 1943 Sheryl Cantwell Vol#: 51

C 1944 Patty L. Clover Vol#: 51

C 1945 Patricia Halpert Vol#: 51

C 1946 Andrea Michele Keith Vol#: 51

C 1947 Virginia Cushman Vol#: 51

C 1948 University California Los Angeles Vol#: 51

C 1949 Hilda W. Cole Vol#: 51

C 1950 Brandes University Vol#: 51

C 1951 Lynne C. Goldsand Vol#: 52

C 1952 Kedutaan Besar Malaysia Emb of Malaysia Vol#: 52

C 1953 PT. Perkebunan Nusantara VI Vol#: 52

C 1954 Hal-Hyatt Goldberg Vol#: 52

C 1955 Laura Hutchinson Vol#: 52

C 1956 National Dairy Council Vol#: 52

C 1957 Phara Marquesa Bourque Vol#: 52

C 1958 Emma McClure & Elmer D. McClure Vol#: 52

C 1959 Yayasan Lembaga Konsumen Indonesia Vol#: 52

C 1960 Bundesministerrium fur Gesundheit Vol#: 52

C 1961 Jayne Sanderson Vol#: 52

C 1962 Carolyn Pearsall White Vol#: 52

C 1963 Lucille Reynolds Vol#: 52

C 1964 Gloria Duncan-Schlagheck Vol#: 52

C 1965 Michelle Lounta Vol#: 52

C 1966 Columbian Government Trade Bureau Vol#: 52

C 1967 Christian Mantilla Barrera Vol#: 52

LET 5 USDA Vol#: 51

LET 6 The Honorable Williams F. Goodling Vol#: 52

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 220 Steven and Tammy Ulibarri Vol#: 6

96P-0436 Reclassify Ohmeda I-NOvent Delivery System

NFR 1 Vol#: 1

98D-1195 Bioanalytical Methods Validation for Human Studies

C 40 Pharmacia & Upjohn Company Vol#: 2

99D-1541 Establishing Pregnancy Registries Draft Guidance Industry

GDL 2 GUIDANCE Vol#: 1

NM 1 Vol#: 1

99D-3082 E10- Choice of Control Group in Clinical Trials

LET 1 Public Citizen's Health Research Group Vol#: 1

99D-4809 Applications Covered by Section 505(b)(2)

C 1 Pfizer Inc Vol#: 1

C 2 Knoll Pharmaceutical Company Vol#: 1

C 3 Bristol-Myers Squibb Company Vol#: 1

99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat

C 7 Wyeth-Ayerst Research Vol#: 1

99D-5199 Resorbable Adhesion Barrier Devices

C 1 FzioMed Inc Vol#: 1

99H-0358 Civil Money Penalty; Retail Enterprises Inc d/b/a Bridges Qu