Theophylline
Theophylline (Anhydrous) Extended-Release Tablets
Approved
Approval ID
c88d2f3e-3478-4ed4-b4da-44dece7818e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
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 Code68151-4210
Application NumberANDA040560
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2014
FDA Product Classification
INGREDIENTS (1)
THEOPHYLLINE ANHYDROUSActive
Quantity: 600 mg in 1 1
Code: 0I55128JYK
Classification: ACTIB