Food and Drug Administration solution

Drug Labeling and Warnings

Drug Details [pdf]

SPL INDEXING DATA ELEMENTS SECTION

INGREDIENTS AND APPEARANCE

Abstract Product Concept

  solution

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	2f841d8f-9841-57b8-4a12-b3f9d1cc4a52

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	30 mg  in 1.5 mL

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	7957db0c-fd4d-d936-6240-4a28390aa77b

Marketing Information
Marketing Category	Application Number or Monograph Citation
NDA	NDA022504

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	cfbe0079-8df4-4a30-f3a8-ccf7877476a4

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA204255

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	3b0cf836-4bd7-54e4-8969-97bc3a6d34d1

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA205328

Application Product Concept

Product Information
Product Type	INDEXING - PRODUCT CONCEPT	Item Code (Source)	a63d685f-d770-5728-4678-5c3e5d19f672

Marketing Information
Marketing Category	Application Number or Monograph Citation
ANDA	ANDA208061

Labeler - Food and Drug Administration (927645523)