Food and Drug Administration 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)	58557864-2f15-2f84-5e50-76c4edd0fb98

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)	OXYBUTYNIN CHLORIDE	5 mg

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	830cc34e-b36d-27d5-9394-5601e840d8e5

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA075079

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	56236a1c-4fb8-726e-b59b-343f69e4c40c

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA071655

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	79fbf949-e08e-7647-5b00-77d9277cd370

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA074625

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	0b05ee51-27cc-795b-f67f-b8fbebd82cc5

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA209823

Labeler - Food and Drug Administration (927645523)