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Friday, October 14, 2011 4:06:32 PM
REQUESTS FOR PRODUCTION
NO. 1: The Abbreviated New Drug Application (“ANDA”), including any amendment(s) thereto, filed by Defendants with the FDA seeking approval to sell a generic enoxaparin product in the United States.
NO. 2: Any Drug Master File (“DMF”), including any amendment(s) thereto, relating to the manufacture of Defendants’ generic enoxaparin product that is the subject of the ANDA referenced in Request No. 1.
NO. 3: Any communications with the FDA regarding Defendants’ generic enoxaparin ANDA and/or any related DMF.
NO. 4: Batch records, including certificates of testing and/or certificates of analysis, for any batch of generic enoxaparin that has been produced, in whole or in part, by (or for) Defendants since August 18, 2009.
NO. 5: Documents sufficient to describe Defendants’ plans for launch and distribution of commercial quantities of generic enoxaparin in the Untied States, including dates upon which Defendants anticipate launching and distributing their generic enoxaparin product.
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