Label: tablet









tablet









  • Category: INDEXING - PRODUCT CONCEPT
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 11, 2017

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  • SPL INDEXING DATA ELEMENTS SECTION

  • INGREDIENTS AND APPEARANCE
    Abstract Product Concept
      tablet
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)10df0ee3-0b2a-17f1-bb91-807769b67541
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI) DEXTROAMPHETAMINE SULFATE5 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)e1756d78-2317-b1db-e1b6-71085fa5591d
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA040361
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)bbcfcb3c-44ca-220b-b02d-2dc295c7cd7b
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA040436
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)8c56b372-05c2-0d5d-7e21-177c69bb1fb0
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA090533
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)7d859133-970c-86d0-4274-1590ca00dbea
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA202893
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)1ed09b00-091a-e90f-4954-45497c968ec4
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA203548
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)2d00e90f-e62d-a61b-dc79-02ab65a9bffd
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA090652
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)6c0e4a07-93df-6689-ef61-f50f133d1bd1
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA206588
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)61fc7f69-c8d9-5585-81de-49e36e81e080
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA204330
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)567d4f2f-ac9f-30e6-ef4a-95609929de98
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA210059
    Abstract Product Concept
      tablet
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)d0777483-fdc8-c03d-6b19-e0f7036bac13
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI) DEXTROAMPHETAMINE SULFATE10 mg
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)4250e998-a46e-8f57-b612-1811155d7823
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA040361
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)9cf94357-1938-b836-ab7d-63bd3424f229
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA040436
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)a2c2f7c6-2ed0-671d-cdce-c8ea504ec886
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA090533
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)a837f789-9274-9011-b812-54eab4c0cec7
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA202893
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)5cf0307e-8361-2e9e-5707-65bb00a85c97
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA090652
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)b7039377-b385-cc13-7813-fedd6da91f27
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA203548
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)27fb0e21-663c-99df-9737-fe62511de321
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA206588
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)5640d961-1724-8f63-e4fa-e6e4f1f92400
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA204330
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)ad4b7f34-928a-50d1-f00b-c74029312627
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA210059
    Labeler - Food and Drug Administration (927645523)
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