Indexing - product concept
- esomeprazole magnesium capsule, delayed release 
- esomeprazole magnesium granule, delayed release 
Food and Drug Administration
Reference Label Set Id: f4853677-1622-4037-688b-fdf533a11d96

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Abstract Product Concept
  capsule, delayed release
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)f9c60630-6ff5-39b5-f6fd-34bf265ad271
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)ea4ed971-74d7-b441-63d1-f51c7e701fa8
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
NDANDA021153
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)52bc7b28-20cf-255d-d1d3-0297b0e83d67
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA078003
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)29bc8fc2-42b6-ba2e-9650-4d3577991d52
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA078936
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)dc04a907-1e10-523d-be3f-8ffd02852c0b
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA202784
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)03f66dd6-6502-8098-329b-f2574d85f0aa
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA078279
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)9b242791-b51d-053c-c950-efed21aad165
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA203636
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)9fef403b-9b73-32d5-305e-2aa796720b9b
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA205606
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)b7c21a8a-7eb5-93fd-b8a3-60a86c6ddc66
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA205563
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)68f06322-2ac2-cb97-05c5-7df0a7da19b3
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA208333
Abstract Product Concept
  capsule, delayed release
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)b7b7c95f-cab7-dda6-f048-cfaeecc97706
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE40 mg
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)cbe12286-ff62-b818-894f-5766e45c0a2b
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
NDANDA021153
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)69bb816d-e2b7-2d24-933f-3c6489ec6256
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA078003
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)8a49b616-1949-37ab-d7e9-e78c98a70d9d
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA078936
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)59d1ba99-202b-1e16-2e5c-7f3c606461a0
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA202784
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)8cbdc183-ef29-139d-c69b-103f598e2574
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA078279
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)3d1f7f40-c60b-d802-7c44-43e7a9185e23
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA203636
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)03a06676-c5c8-ddf3-a4fc-62a46e56e5ad
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA205606
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)52460d4e-c87d-80ef-0166-318cb8754507
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA205563
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)181f17dd-652e-6b74-ba3f-b1d47a74a5e3
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
ANDAANDA208333
Abstract Product Concept
  granule, delayed release
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)63c4e71c-335b-de22-c726-3ec86f6b21b5
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE2.5 mg
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)fe50be60-a1af-327e-02c0-627bd4a1d859
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
NDANDA021957
Abstract Product Concept
  granule, delayed release
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)60b281b4-9a53-05f4-7b83-90ffb50d440a
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE5 mg
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)5009ea27-4028-a54b-74c1-c65a636c13de
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
NDANDA021957
Abstract Product Concept
  granule, delayed release
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)3ad4553d-ea35-46fa-3c0d-6aa52843e9cb
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE10 mg
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)e4292909-74e1-085a-4cd3-ffd8dde97a28
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
NDANDA022101
Abstract Product Concept
  granule, delayed release
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)32683610-0888-1090-0a2e-d25758ca5e46
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)64c6b1a6-2cd5-4f37-bb3c-461ea9a091ed
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
NDANDA021957
Abstract Product Concept
  granule, delayed release
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)d7e7d73a-9d11-7772-e48c-9dfc5fb4eca9
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE40 mg
Application Product Concept
Product Information
Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)59ceedda-e04e-ff08-613a-d1414a743af3
Marketing Information
Marketing CategoryApplication Number or Monograph Citation
NDANDA021957
Labeler - Food and Drug Administration (927645523)

Revised: 12/2017
Document Id: c37d5f74-8ec2-4173-aac9-1d57ef2831c2
Set id: d71865e8-5c35-4d76-8ecd-a7adda982240
Version: 8
Effective Time: 20171212
 
Food and Drug Administration