Theophylline
Theophylline (Anhydrous) Extended-Release Tablets
Approved
Approval ID
fc61fd7e-63ca-4714-851f-31b2a045903d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Theophylline
PRODUCT DETAILS
NDC Product Code53808-0315
Application NumberANDA089808
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 25, 2010
Generic NameTheophylline
INGREDIENTS (5)
THEOPHYLLINE ANHYDROUSActive
Quantity: 200 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Theophylline
PRODUCT DETAILS
NDC Product Code53808-0316
Application NumberANDA089763
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 25, 2010
Generic NameTheophylline
INGREDIENTS (5)
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT