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            <name>Norbrook Laboratories Limited</name>
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                     <manufacturedProduct>
                        <code code="55529-165" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Defendazole</name>
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                              <name>FENBENDAZOLE</name>
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                              <numerator value="100" unit="mg"/>
                              <denominator value="1" unit="mL"/>
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                              <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FENBENDAZOLE</name>
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                                    <code code="621BVT9M36" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FENBENDAZOLE</name>
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                              <numerator value="1000" unit="mL"/>
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                           <statusCode code="active"/>
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                              <low value="20260119"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>INDICATIONS:
</title>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">Beef and Dairy Cattle</content> – 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: <content styleCode="bold">Lungworms:</content> Adult <content styleCode="italics">Dictyocaulus viviparus</content>; <content styleCode="bold">Stomach worms:</content> Adult brown stomach worms <content styleCode="italics">(Ostertagia ostertagi)</content>, Adult and fourth stage larvae barberpole worms <content styleCode="italics">(Haemonchus contortus &amp; H. placei)</content>, and Adult and fourth stage larvae small stomach worms <content styleCode="italics">(Trichostrongylus axei)</content>; <content styleCode="bold">Intestinal worms</content> (Adult and fourth stage larvae): hookworms <content styleCode="italics">(Bunostomum phlebotomum)</content>, thread-necked intestinal worms <content styleCode="italics">(Nematodirus helvetianus)</content>, small intestinal worms <content styleCode="italics">(Cooperia punctata &amp; C. oncophora)</content>, bankrupt worms <content styleCode="italics">(Trichostrongylus colubriformis)</content>, and nodular worms <content styleCode="italics">(Oesophagostomum radiatum)</content>.
</paragraph>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">Goats</content> – 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: <content styleCode="bold">Stomach worms</content> (adults): <content styleCode="italics">Haemonchus contortus</content> and <content styleCode="italics">Teladorsagia circumcincta</content>.
</paragraph>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DIRECTIONS:
</title>
               <text>
                  <paragraph>Administer orally. The recommended dose of 2.3 mg/lb (5 mg/kg) of body weight is achieved when 2.3 mL of the drug are given for each 100 lb body weight.
</paragraph>
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               <title>EXAMPLES:
</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Cattle:</content>
                  </paragraph>
                  <table width="100%" styleCode="Noautorules">
                     <col width="61.450%" align="left"/>
                     <col width="38.550%" align="left"/>
                     <tbody>
                        <tr>
                           <td align="center" valign="top">
                              <content styleCode="underline">Body Weight</content>
                           </td>
                           <td align="center" valign="top">
                              <content styleCode="underline">Amount</content>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">100 lb
</td>
                           <td align="center" valign="top">2.3 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">200 lb
</td>
                           <td align="center" valign="top">4.6 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">300 lb
</td>
                           <td align="center" valign="top">6.9 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">400 lb
</td>
                           <td align="center" valign="top">9.2 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">500 lb
</td>
                           <td align="center" valign="top">11.5 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">1000 lb
</td>
                           <td align="center" valign="top">23.0 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">1500 lb
</td>
                           <td align="center" valign="top">34.5 mL
</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>
                     <content styleCode="bold">Goats :</content>
                  </paragraph>
                  <table width="100%" styleCode="Noautorules">
                     <col width="62.450%" align="left"/>
                     <col width="37.550%" align="left"/>
                     <tbody>
                        <tr>
                           <td align="center" valign="top">
                              <content styleCode="underline">Body Weight</content>
                           </td>
                           <td align="center" valign="top">
                              <content styleCode="underline">Amount</content>
                           </td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">25 lb
</td>
                           <td align="center" valign="top">0.6 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">50 lb
</td>
                           <td align="center" valign="top">1.2 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">75 lb
</td>
                           <td align="center" valign="top">1.7 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">100 lb
</td>
                           <td align="center" valign="top">2.3 mL
</td>
                        </tr>
                        <tr>
                           <td align="center" valign="top">125 lb
</td>
                           <td align="center" valign="top">2.9 mL
</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph>Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.
</paragraph>
               </text>
               <effectiveTime value="20260115"/>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNINGS:
</title>
               <text>
                  <paragraph>NOT FOR USE IN HUMANS.<br/>KEEP OUT OF REACH OF CHILDREN.
</paragraph>
                  <paragraph>The Safety Data Sheet (SDS) contains more detailed occupational safety information.
</paragraph>
               </text>
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Contact Information:
</title>
                     <text>
                        <paragraph>For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-866-591-5777.
</paragraph>
                        <paragraph>For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae
</paragraph>
                     </text>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>OTHER WARNINGS:
</title>
               <text>
                  <paragraph>Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.
</paragraph>
                  <paragraph>Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.
</paragraph>
                  <paragraph>Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).
</paragraph>
                  <paragraph>A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.
</paragraph>
                  <paragraph>
                     <content styleCode="bold">Restricted drug (California) – use only as directed.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Store at temperatures between 59 °F (15 °C) and 86 °F (30 °C).</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Excursions are permitted up to 104 °F (40 °C) however such exposure should be minimized. Brief exposure to temperatures down to 36 °F (2 °C) may be tolerated.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Protect from freezing. Shake well before use.</content>
                  </paragraph>
               </text>
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Withdrawal Periods and Residue Warnings:
</title>
                     <text>
                        <paragraph>Milk taken from cows during treatment and for 48 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.
</paragraph>
                        <paragraph>Goats must not be slaughtered for human consumption within 6 days following last treatment with this drug product. Because a milk discard time has not been established, do not use in lactating goats.
</paragraph>
                        <paragraph>Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.
</paragraph>
                        <paragraph>Made in the UK
</paragraph>
                        <paragraph>Norbrook Laboratories Limited<br/>Newry, Co. Down, BT35 6QQ,<br/>Northern Ireland.
</paragraph>
                        <paragraph>Approved by FDA under ANADA # 200-831
</paragraph>
                        <paragraph>Defendazole™ is a trademark of Norbrook Laboratories Limited
</paragraph>
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               <title>Principal Display Panel - 100 mg/mL Carton Label
</title>
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                  <paragraph>NDC 55529-165-08
</paragraph>
                  <paragraph>
                     <content styleCode="bold">Defend</content>azole™<br/>(fenbendazole)
</paragraph>
                  <paragraph>
                     <content styleCode="bold">Dewormer<br/>
                     </content>for <content styleCode="bold">Beef &amp; Dairy Cattle<br/>
                     </content>and <content styleCode="bold">Goats</content>
                  </paragraph>
                  <paragraph>Suspension 10%<br/>(100 mg/mL)
</paragraph>
                  <paragraph>5 Liter<br/>(169 fl oz.)
</paragraph>
                  <paragraph>
                     <content styleCode="bold italics">Norbrook<sup>®</sup>
                     </content>
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               <title>Principal Display Panel - 100 mg/mL Jug Label
</title>
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                  <paragraph>NDC 55529-165-08
</paragraph>
                  <paragraph>
                     <content styleCode="bold">Defend</content>azole™<br/>(fenbendazole)
</paragraph>
                  <paragraph>
                     <content styleCode="bold">Dewormer<br/>
                     </content>for <content styleCode="bold">Beef &amp; Dairy Cattle<br/>
                     </content>and <content styleCode="bold">Goats</content>
                  </paragraph>
                  <paragraph>Suspension 10%<br/>(100 mg/mL)
</paragraph>
                  <paragraph>5 Liter<br/>(169 fl oz.)
</paragraph>
                  <paragraph>
                     <content styleCode="bold italics">Norbrook<sup>®</sup>
                     </content>
                  </paragraph>
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