theophylline
Theophylline Extended-Release Tablets Rx only
Approved
Approval ID
b0d5d1cd-c79b-4229-929c-2eb3e4f43298
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code60219-2045
Application NumberANDA216276
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 22, 2023
Generic Nametheophylline
INGREDIENTS (5)
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
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
theophylline
PRODUCT DETAILS
NDC Product Code60219-2046
Application NumberANDA216276
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 22, 2023
Generic Nametheophylline
INGREDIENTS (5)
THEOPHYLLINE ANHYDROUSActive
Quantity: 450 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT