Adderall XR definition

Adderall XR means the pharmaceutical products which are approved for Marketing in the Territory pursuant to the NDA.
Adderall XR means the extended release mixed amphetamine pharmaceutical product currently sold under NDA #21-303.
Adderall XR means the pharmaceutical product that contains the Compound as its sole active ingredient which is approved for Marketing in the Territory pursuant to Shire’s NDA and sold under the trade name Adderall XR.

Examples of Adderall XR in a sentence

  • See Tracy Staton, FDA hits Shire with early nod for Adderall XR copycat, FiercePharma, June 25, 2012, available at http://www.fiercepharma.com/story/fda-hits-shire-early-nod- adderall-xr-copycat/2012-06-25.

  • For instance, with annual sales for Adderall XR at $1.5 billion the year before generic entry, sales for the two previous years were estimated to be $1.364 billion and $1.239 billion, for a total of $4.103 billion.

  • The section includes a table describing how to switch directly from Adderall XR to this product.

  • See 21 U.S.C. § 355(j); see also In re Adderall XR Antitrust Litig., 754 F.3d 128, 130 (2d Cir.

  • Shire and Neos have entered into a licensing agreement that will allow Neos to market this product immediately on approval even though Shire holds patents for Adderall XR that expire as late as April 21, 2019.

  • Shire Pharmaceuticals introduced an extended release version of its ADHD drug called Adderall XR in 2001.

  • See, e.g., In re Adderall XR Antitrust Litig., 754 F.3d 128, 135 (2d Cir.

  • Requests for amphetamine/dextroamphetamine salt combination (Adderall, Adderall XR) agents may not be approved for the following: A.

  • A randomized, double-blind, placebo- controlled, parallel-group study of SLI381 (Adderall XR) in children with attention deficit/ hyperactivity disorder.

  • To compare the rate of absorption and oral bioavailability of amphetamine XR-ODT 18.8 mg and oral Adderall XR 30 mg following an overnight fast of at least 10 hours.

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