|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dockets Entered
On June 25, 2003
TABLE OF
CONTENTS (Linked) |
|
|
|
|
|
|
|
|
|
|
|
Docket #
|
|
Title
|
|
|
|
|
|
|
|
1975N-0183H
|
|
Health-Care Antiseptic Drug
Products for OTC Human Use |
|
|
|
1976N-0377
|
|
Certain Drugs Containing Fluoxymesterone
& Ethinyl Estrad |
|
|
|
1995N-0309
|
|
CGMPs for the Production of
Infant Formula |
|
|
|
1996N-0417
|
|
CGMP in Mfg. Packing or Holding
Dietary Supplements
|
|
|
|
1997S-0163
|
|
Dietary Supplements, Courtesy
Letters (Letters of Objection) |
|
|
|
1998P-1041
|
|
Withdrawn from sale of Tylosterone
Tablets |
|
|
|
|
|
1999D-1738
|
|
Bioavilability & Bioequivalence
Studies for Nasal Aerosols |
|
|
|
2000N-1571
|
|
Enrofloxacin for Poultry: Opportunity
for Hearing |
|
| CONTENTS |
|
|
1975N-0183H |
|
Health-Care
Antiseptic Drug Products for OTC Human Use |
|
|
|
LET 42 |
|
Buchanan Ingersoll |
|
Vol #: |
|
149 |
|
|
|
|
|
1976N-0377 |
|
Certain
Drugs Containing Fluoxymesterone & Ethinyl Estrad |
|
|
|
SUP 2 |
|
Solvay Pharmaceuticals, Inc.
|
|
Vol #: |
|
6 |
|
|
|
|
|
1991N-0245 |
|
Cosmetic Products Containing
Certain Hormone Ingredients |
|
|
|
|
|
C 2 |
|
Form Letters |
|
Vol #: |
|
3 |
|
|
|
|
|
C 3 |
|
Peggy Marko-Sprague
|
|
Vol #: |
|
2 |
|
|
|
|
|
1995N-0309 |
|
CGMPs
for the Production of Infant Formula |
|
|
|
C 15 |
|
Gulf Coast Retailers Assn,
Inc. |
|
Vol #: |
|
9 |
|
|
|
|
|
C 16 |
|
SHS International, Ltd.
|
|
Vol #: |
|
9 |
|
|
|
|
|
1996N-0417 |
|
CGMP
in Mfg. Packing or Holding Dietary Supplements |
|
|
|
C 123 |
|
American Academy of Pediatrics
|
|
Vol #: |
|
17 |
|
|
|
|
|
C 124 |
|
International Food Additive
Council (IFAC) |
|
Vol #: |
|
17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1997S-0163 |
|
Dietary
Supplements, Courtesy Letters (Letters of Objection) |
|
|
|
LET 702 |
|
HFS-800 to Prostate Rx, Inc.
|
|
Vol #: |
|
21 |
|
|
|
|
|
LET 703 |
|
HFS-800 to New Chapter, Inc.
|
|
Vol #: |
|
21 |
|
|
|
|
|
LET 704 |
|
HFS-800 to National Vitamin
Company, Inc. |
|
Vol #: |
|
21 |
|
|
|
|
|
LET 705 |
|
HFS-800 to New Chapter, Inc.
|
|
Vol #: |
|
21 |
|
|
|
|
|
1997V-0238 |
|
Laser Fantasy International
- Rainbow I Projector |
|
|
|
VRA 3 |
|
HFZ-300 to Sight & Sound
Ministries, Inc. |
|
Vol #: |
|
1 |
|
|
|
|
|
1998P-1041 |
|
Withdrawn
from sale of Tylosterone Tablets |
|
|
|
SUP 1 |
|
Solvay Pharmaceuticals, Inc.
|
|
Vol #: |
|
3 |
|
|
|
|
|
1999D-1738 |
|
Bioavilability
& Bioequivalence Studies for Nasal Aerosols |
|
|
|
C 19 |
|
Aventis Pharmaceuticals
|
|
Vol #: |
|
2 |
|
|
|
|
|
1999P-1656 |
|
Draft Regulatory Procedures
regarding Warning Letters on web |
|
|
|
N 1
|
|
FDA |
|
Vol #: |
|
1 |
|
|
|
|
|
PAV 1 |
|
FDA to Kirkpatrick & Lockhart,
LLP |
|
Vol #: |
|
1 |
|
|
|
|
|
2000N-1571 |
|
Enrofloxacin
for Poultry: Opportunity for Hearing |
|
|
|
CS 45 |
|
HFA-305 |
|
Vol #: |
|
378 |
|
|
|
|
|
OR 47 |
|
HF-3 |
|
Vol #: |
|
378 |
|
|
|
|
|
2001V-0070 |
|
Laser Light Show |
|
|
|
|
|
|
|
VRA 1 |
|
HFZ-300 to Hersheypark
|
|
Vol #: |
|
1 |
|
|
|
|
|
2002H-0443 |
|
Civil Money Penalty Re: LaHaye
Ctr.for Advanced Eye Care |
|
|
|
|
|
|
|
AMD 1 |
|
GCF-1 (General Counsel)
|
|
Vol #: |
|
1 |
|
|
|
|
|
CS 12 |
|
HFA-305 |
|
Vol #: |
|
1 |
|
|
|
|
|
CS 13 |
|
HFA-305 |
|
Vol #: |
|
1 |
|
|
|
|
|
OR 10 |
|
HF-3 |
|
Vol #: |
|
1 |
|
|
|
|
|
OR 11 |
|
HF-3 |
|
Vol #: |
|
1 |
|
|
|
|
|
RMO 1 |
|
GCF-1 General Counsel
|
|
Vol #: |
|
1 |
|
|
|
|
|
2003D-0226 |
|
Draft Guidance for Industry
and FDA Staff; Compliance with Section 301 of the Medical Device
User Fee and Modernization Act of 2002 b Identification of Manufacturer
of Medical Devices; Availability |
|
|
|
|
|
GDL 1
|
|
Draft Guidance for Industry
& FDA Staff |
|
Vol #: |
|
1 |
|
|
|
|
|
NAD 1
|
|
FDA |
|
Vol #: |
|
1 |
|
