Page 7 - Orange Book Cumulative Supplement 10 October 2012

APP PHARMACEUTICALS FRESENIUS KABI USA LLC
(APP PHARMS (FRESENIUS KABI USA)

APP PHARMACEUTICALS LLC FRESENIUS KABI USA LLC
(APP PHARMS) (FRESENIUS KABI USA)

NEXUS PHARMACEUTICALS FRESENIUS KABI USA LLC
(NEXUS PHARMS) (FRESENIUS KABI USA)

OVATION PHARMACEUTICALS INC OAK PHARMACEUTICALS INC
(OVATION PHARMS) (OAK PHARMS)

ROSS LABORATORIES DIV ABBOTT ABBVIE INC
LABORATORIES
(ROSS LABS) (ABBVIE)

SOLVAY PHARMACEUTICALS ABBVIE INC
(SOLVAY) (ABBVIE)

UNIMED PHARMACEUTICALS INC ABBVIE INC
(UNIMED PHARMS) (ABBVIE)

1.4 LEVOTHYROXINE SODIUM

Because there are multiple reference listed drugs of levothyroxine sodium
tablets and some reference listed drugs' sponsors have conducted studies
to establish their drugs' therapeutic equivalence to other reference
listed drugs, FDA has determined that its usual practice of assigning two
or three character TE codes may be potentially confusing and inadequate
for these drug products. Accordingly, FDA provides the following
explanation and chart of therapeutic equivalence evaluations for
levothyroxine sodium drug products.

Levothyroxine Sodium (Mylan ANDA 76187) and Levo-T (Alara NDA 21342)
tablets have been determined to be therapeutically equivalent to
corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets.
Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187),
Unithroid (Jerome Stevens NDA 021210), and Levothyroxine Sodium (Merck
KGAA ANDA 76752)tablets have been determined to be therapeutically
equivalent to corresponding strengths of Synthroid (Abbott NDA 021402)
tablets.

Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210),
Levothyroxine Sodium (Mylan ANDA 076187), and Levothyroxine Sodium (Merck
KGAA ANDA 76752) tablets have been determined to be therapeutically
equivalent to corresponding strengths of Levoxyl (King Pharms NDA 021301)
tablets.

Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to
be therapeutically equivalent to corresponding strengths of Levothroid
(Lloyd NDA 021116) tablets.

The chart outlines TE codes for all 0.025mg products. Other product
strengths may be similar. Therapeutic equivalence has been established
between products that have the same AB+number TE code. More than one TE
code may apply to some products. One common TE code indicates therapeutic
equivalence between products.

Trade Name Applicant Potency TE Code Appl No Product No
UNITHROID STEVENS J 0.025MG AB1 21210 001
LEVOTHYROXINE MYLAN 0.025MG AB1 76187 001
SODIUM
LEVOXYL KING PHARMS 0.025MG AB1 21301 001
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