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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0315
Application NumberANDA089808
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2010
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0316
Application NumberANDA089763
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2010
FDA Product Classification
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