Label: injection












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

Drug Label Information

Updated December 13, 2017

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  • SPL INDEXING DATA ELEMENTS SECTION

  • INGREDIENTS AND APPEARANCE
    Abstract Product Concept
      injection
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)1ac86922-0a05-211b-cb92-3845b8decbd0
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE50 mg  in 1 mL
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)7aa839ed-c278-61ab-d36a-806f910b6723
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA075761
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)d2150803-93c8-f867-b6bd-95a6045c1d52
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA075955
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)7e543a38-93bb-e000-8e28-d2950d7f4182
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA076217
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)7a3c803a-1f34-61cc-ad26-b7a125b1301e
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA076232
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)b66345bb-9440-2404-9071-39bae8f3a7e2
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA077161
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)4f4a9d99-d75d-6ed4-a15a-9a6b8e331efd
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA077234
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)e11409f8-d1f0-5fe7-1c8a-491d65e46db8
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA077610
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)2ad5e122-edce-b90a-24a0-ed75a0adb7b4
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA077834
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)7d95a1ff-e8fa-3bc1-cf09-2377bdd7f690
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA022325
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)712dd1b1-e9cc-fb89-a95a-e65b929ac628
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA203884
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)dce99573-ca24-0b73-4e21-a7e09f50ed4d
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA203885
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)0998257e-2369-e815-d957-a4fb8ac6970c
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    ANDAANDA204550
    Labeler - Food and Drug Administration (927645523)
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