Page 8 - Orange Book Cumulative Supplement 10 October 2012

SYNTHROID ABBOTT 0.025MG AB1 21402 001
LEVO-T ALARA PHARM 0.025MG AB1 21342 001

SYNTHROID ABBOTT 0.025MG AB2 21402 001
LEVOTHYROXINE MYLAN 0.025MG AB2 76187 001
SODIUM
LEVO-T ALARA PHARM 0.025MG AB2 21342 001
UNITHROID STEVENS J 0.025MG AB2 21210 001
LEVOTHYROXINE MERCK KGAA 0.025MG AB2 76752 001
SODIUM

LEVOXYL KUNG PHARMS 0.025MG AB3 21301 001
LEVO-T ALARA PHARM 0.025MG AB3 21342 001
UNITHROID STEVENS J 0.025MG AB3 21210 001
LEVOTHYROXINE MYLAN 0.025MG AB3 76187 001
SODIUM
LEVOTHYROXINE MERCK KGAA 0.025MG AB3 76752 001
SODIUM

LEVOTHROID LLOYD 0.025MG AB4 21116 001
LEVOTHYROXINE MYLAN 0.025MG AB4 76187 001
SODIUM

1.5 AVAILABILITY OF THE EDITION

Since 1997, the Electronic Orange Book Query (EOBQ)
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm, has been
available on the internet and has become the updated-every-month Orange
Book. The Query provides searching of the approved drug list by active
ingredient, proprietary name, applicant holder, applicant number or patent
number. Product search categories are: prescription, over-the-counter,
discontinued drugs. There are links to patent and exclusivity information
that may be applicable to each product.

Commencing with the 25th edition, the Annual Edition and monthly
Cumulative Supplements have been provided in downloadable Portable
Document Format (PDF) at the EOB home page by clicking on Publications.
The PDF annual and cumulative supplements duplicate previous paper
versions. Over time, there will be an archive for the annuals and each
year's December Cumulative Supplement.
The downloaded Annual Edition and Cumulative Supplements are also
available in a paper version (Approved Drug Products with Therapeutic
Equivalence Evaluations, ADP) from the U.S. Government Printing Office:
http://bookstore.gpo.gov; toll free 866-512-1800.

There are historical lists of Orange Book cumulative supplement product
monthly changes at
http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm. There are
ASCII text files of the Orange Book drug product, patent, and exclusivity
data at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm. The
drug product text files are provided in eobzip.zip format. The files are
updated concurrently with the monthly cumulative supplements. The annual
Orange Book Edition Appendices A, B, and C in PDF format are updated
quarterly.

Effective August 18, 2003, patent submissions for publication in the
Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542
which may be downloaded from the FDA Forms List,
http://www.fda.gov/opacom/morechoices/fdaforms/default.html.

The current listing of the Orphan Product Designations and Approvals is

available at http://www.fda.gov/orphan/designat/list.htm.

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