AMRIX® definition

AMRIX® means the drug listed in the FDA Orange Book under NDA 21-777, cyclobenzaprine hydrochloride extended release capsule, and any supplements thereto relating to additional strengths.
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Examples of AMRIX® in a sentence

  • Impax represents that ANDA No 90-771 is its only application for approval referencing the AMRIX® product, and further represents that it neither filed nor assisted in the Suitability Petition currently docketed at the FDA as Docket No. FDA 2009 P 0168.

Related to AMRIX®

  • CTI means CTI Logistics Limited (ABN 69 008 778 925) and/or any Affiliate of CTI Logistics Limited as the case may be, which performs all or any of the Services.

  • NPS means nominal pipe size.

  • Shire means Shire of Augusta Margaret River

  • Novartis shall have the meaning set forth in the Preamble.

  • Elan means Elan Corp and its Affiliates.