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Chronological List of Petitions and Advisory Opinions
From January 1, 2008 through December 31, 2008
To view actual documents, make a note of the docket number, go to Dockets Management , enter the docket number in the search box. You will then get everything associated with that docket number.
"65FR78494" indicates a notice of some kind was published in the Federal Register
(FR) for a particular date. The FR can be found at http://www.fda.gov/ohrms/dockets/ and then go to the Federal Register section.
Interim Response is not a final decision on the petition.
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| CHRONOLOGICAL LIST OF PETITIONS AND ADVISORY OPINIONS
January
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| Date Filed |
Docket # |
Name of Petitioner/Subject
Matter |
Disposition |
| January |
| *01/02/2008 |
2008P-0001 |
Odan Laboratories, Inc./Determine that an abbreviated new
drug application is suitable for a non- aerosol oral spray anesthetic
delivering 10 mg lidocaine per metered dose.
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Pending |
| *01/02/2008 |
2005N-0279 |
Carolyn Smith/Food Labeling; Gluten-Free Labeling of Foods |
Pending |
| *01/03/2008 |
2008P-0002 |
Cobe Chem Labs/Request to submit an Abbreviated New Drug Application
for Tretinoin Cream in strength of 0.1%. |
Pending |
| *01/03/2008 |
2008P-0003 |
Ebewe Pharma/Determine whether a 1 gm/20 mL (50 mg/mL) presentation
of Fluorouracil Injection, |
Pending |
| *01/03/2008 |
2008P-0006 |
Lachman Consultant Services, Inc./To determine whether Didrex
25 mg (benzphetmine hydrochloride) Tablets (NDA 12-427) by Pharmacia
and Upjohn Company, has been voluntarily withdrawn or withheld
from sale for safety or efficacy reasons |
Pending |
Page updated
February 14, 2008
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