Theophylline
Theophylline Extended-Release Tablets Rx only
Approved
Approval ID
bf320619-c53b-49a7-97b5-cd0c075a9f75
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-077
Application NumberANDA217422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (5)
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
THEOPHYLLINE ANHYDROUSActive
Quantity: 300 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB
Theophylline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-078
Application NumberANDA217422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
THEOPHYLLINE ANHYDROUSActive
Quantity: 450 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB