capsule, delayed release capsule, delayed release granule, delayed release granule, delayed release granule, delayed release granule, delayed release granule, delayed release

Drug Labeling and Warnings

Drug Details [pdf]

SPL INDEXING DATA ELEMENTS SECTION

INGREDIENTS AND APPEARANCE

Abstract Product Concept

  capsule, delayed release

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	f9c60630-6ff5-39b5-f6fd-34bf265ad271

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	ea4ed971-74d7-b441-63d1-f51c7e701fa8

Marketing Information
Marketing Category	Application Number or Monograph Citation
NDA	NDA021153

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	52bc7b28-20cf-255d-d1d3-0297b0e83d67

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA078003

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	29bc8fc2-42b6-ba2e-9650-4d3577991d52

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA078936

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	dc04a907-1e10-523d-be3f-8ffd02852c0b

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA202784

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	03f66dd6-6502-8098-329b-f2574d85f0aa

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA078279

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	9b242791-b51d-053c-c950-efed21aad165

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA203636

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	9fef403b-9b73-32d5-305e-2aa796720b9b

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA205606

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	b7c21a8a-7eb5-93fd-b8a3-60a86c6ddc66

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA205563

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	68f06322-2ac2-cb97-05c5-7df0a7da19b3

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA208333

Abstract Product Concept

  capsule, delayed release

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	b7b7c95f-cab7-dda6-f048-cfaeecc97706

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	40 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	cbe12286-ff62-b818-894f-5766e45c0a2b

Marketing Information
Marketing Category	Application Number or Monograph Citation
NDA	NDA021153

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	69bb816d-e2b7-2d24-933f-3c6489ec6256

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA078003

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	8a49b616-1949-37ab-d7e9-e78c98a70d9d

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA078936

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	59d1ba99-202b-1e16-2e5c-7f3c606461a0

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA202784

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	8cbdc183-ef29-139d-c69b-103f598e2574

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA078279

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	3d1f7f40-c60b-d802-7c44-43e7a9185e23

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA203636

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	03a06676-c5c8-ddf3-a4fc-62a46e56e5ad

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA205606

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	52460d4e-c87d-80ef-0166-318cb8754507

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA205563

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	181f17dd-652e-6b74-ba3f-b1d47a74a5e3

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA208333

Abstract Product Concept

  granule, delayed release

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	63c4e71c-335b-de22-c726-3ec86f6b21b5

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	2.5 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	fe50be60-a1af-327e-02c0-627bd4a1d859

Marketing Information
Marketing Category	Application Number or Monograph Citation
NDA	NDA021957

Abstract Product Concept

  granule, delayed release

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	60b281b4-9a53-05f4-7b83-90ffb50d440a

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	5 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	5009ea27-4028-a54b-74c1-c65a636c13de

Marketing Information
Marketing Category	Application Number or Monograph Citation
NDA	NDA021957

Abstract Product Concept

  granule, delayed release

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	3ad4553d-ea35-46fa-3c0d-6aa52843e9cb

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	10 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	e4292909-74e1-085a-4cd3-ffd8dde97a28

Marketing Information
Marketing Category	Application Number or Monograph Citation
NDA	NDA022101

Abstract Product Concept

  granule, delayed release

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	32683610-0888-1090-0a2e-d25758ca5e46

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	64c6b1a6-2cd5-4f37-bb3c-461ea9a091ed

Marketing Information
Marketing Category	Application Number or Monograph Citation
NDA	NDA021957

Abstract Product Concept

  granule, delayed release

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	d7e7d73a-9d11-7772-e48c-9dfc5fb4eca9

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	40 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	59ceedda-e04e-ff08-613a-d1414a743af3

Marketing Information
Marketing Category	Application Number or Monograph Citation
NDA	NDA021957

Labeler - Food and Drug Administration (927645523)