tablet tablet

Drug Labeling and Warnings

Drug Details [pdf]

SPL INDEXING DATA ELEMENTS SECTION

INGREDIENTS AND APPEARANCE

Abstract Product Concept

  tablet

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	10df0ee3-0b2a-17f1-bb91-807769b67541

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)	DEXTROAMPHETAMINE SULFATE	5 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	e1756d78-2317-b1db-e1b6-71085fa5591d

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA040361

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	bbcfcb3c-44ca-220b-b02d-2dc295c7cd7b

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA040436

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	8c56b372-05c2-0d5d-7e21-177c69bb1fb0

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA090533

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	7d859133-970c-86d0-4274-1590ca00dbea

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA202893

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	1ed09b00-091a-e90f-4954-45497c968ec4

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA203548

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	2d00e90f-e62d-a61b-dc79-02ab65a9bffd

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA090652

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	6c0e4a07-93df-6689-ef61-f50f133d1bd1

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA206588

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	61fc7f69-c8d9-5585-81de-49e36e81e080

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA204330

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	567d4f2f-ac9f-30e6-ef4a-95609929de98

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA210059

Abstract Product Concept

  tablet

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	d0777483-fdc8-c03d-6b19-e0f7036bac13

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)	DEXTROAMPHETAMINE SULFATE	10 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	4250e998-a46e-8f57-b612-1811155d7823

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA040361

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	9cf94357-1938-b836-ab7d-63bd3424f229

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA040436

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	a2c2f7c6-2ed0-671d-cdce-c8ea504ec886

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA090533

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	a837f789-9274-9011-b812-54eab4c0cec7

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA202893

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	5cf0307e-8361-2e9e-5707-65bb00a85c97

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA090652

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	b7039377-b385-cc13-7813-fedd6da91f27

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA203548

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	27fb0e21-663c-99df-9737-fe62511de321

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA206588

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	5640d961-1724-8f63-e4fa-e6e4f1f92400

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA204330

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	ad4b7f34-928a-50d1-f00b-c74029312627

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA210059

Labeler - Food and Drug Administration (927645523)