Theophylline
Theophylline Extended-Release Tablets Rx only
Approved
Approval ID
88d863a5-63ab-4b29-b181-6d7db38234ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2014
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Theophylline
PRODUCT DETAILS
NDC Product Code53808-0982
Application NumberANDA090430
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 24, 2014
Generic NameTheophylline
INGREDIENTS (5)
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT