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
NDC Product Code52244-400
Application NumberANDA081034
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 30, 2017
Generic Nametheophylline anhydrous
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 400 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
theophylline anhydrous
PRODUCT DETAILS
NDC Product Code52244-300
Application NumberANDA087944
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 30, 2017
Generic Nametheophylline anhydrous
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
theophylline anhydrous
PRODUCT DETAILS
NDC Product Code52244-100
Application NumberANDA087942
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 30, 2017
Generic Nametheophylline anhydrous
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 100 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
theophylline anhydrous
PRODUCT DETAILS
NDC Product Code52244-200
Application NumberANDA087943
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 30, 2017
Generic Nametheophylline anhydrous
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 200 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB