| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On April 26, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1981N-0033A
|
| Oral Health Care Drug Product; Oral Antiseptic Drug Products
|
|
|
|
|
| 1983P-0187
|
| REFRAIN FROM APPROVAL POLYURETHANE CONTRACEPTIVE SPONGE
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| 2005P-0161
|
| ANDA Suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Tablets
|
|
|
|
|
| 2005P-0162
|
| ANDA suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/ 5 mL.
|
|
|
|
|
| 1981N-0033A
|
| Oral Health Care Drug Product; Oral Antiseptic Drug Products
|
|
|
|
|
| PDN
1
|
| HFC-1 to Olsson Frank and Weeda PC
|
| Vol #:
|
| 17
|
|
|
|
|
| 1983P-0187
|
| REFRAIN FROM APPROVAL POLYURETHANE CONTRACEPTIVE SPONGE
|
|
|
|
|
| PDN
2
|
| HFD-001 to Associated Pharmacologists & Toxicologists
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
|
|
|
|
| MO
12
|
| Hen\\\Korangy Radiology Associates, P.A., et al
|
| Vol #:
|
| 8
|
|
|
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
|
|
|
| C 37
|
| J. E. Miller
|
| Vol #:
|
| 1
|
|
|
|
|
| C 38
|
| Dr. J. H. BoylesJr.
|
| Vol #:
|
| 1
|
|
|
|
|
| C 39
|
| Harriet Babcock
|
| Vol #:
|
| 1
|
|
|
|
|
| C 40
|
| I. Stupack
|
| Vol #:
|
| 1
|
|
|
|
|
| C 41
|
| L. K. Hunt
|
| Vol #:
|
| 1
|
|
|
|
|
| C 42
|
| M. M. Wood
|
| Vol #:
|
| 1
|
|
|
|
|
| C 43
|
| F. G. Norris
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
1
|
| HFS-830
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| C 24
|
| I. Stupack
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0161
|
| ANDA Suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Tablets
|
|
|
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0162
|
| ANDA suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/ 5 mL.
|
|
|
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
