Theo-24
Theo-24 (theophylline anhydrous) Extended-release capsules 100, 200, 300, & 400 mg
Approved
Approval ID
7a108fa0-c230-475f-be93-6f864b98a410
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2017
Manufacturers
FDA
Endo Pharmaceuticals, Inc.
DUNS: 178074951
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
theophylline anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52244-400
Application NumberANDA081034
Product Classification
M
Marketing Category
C73584
G
Generic Name
theophylline anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2017
FDA Product Classification
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 400 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
theophylline anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52244-300
Application NumberANDA087944
Product Classification
M
Marketing Category
C73584
G
Generic Name
theophylline anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2017
FDA Product Classification
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
theophylline anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52244-100
Application NumberANDA087942
Product Classification
M
Marketing Category
C73584
G
Generic Name
theophylline anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2017
FDA Product Classification
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 100 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
theophylline anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52244-200
Application NumberANDA087943
Product Classification
M
Marketing Category
C73584
G
Generic Name
theophylline anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2017
FDA Product Classification
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 200 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB