ELIXOPHYLLIN
Rx Only
Approved
Approval ID
7a5a367f-8461-4b15-99fc-f89aa7d5936e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2010
Manufacturers
FDA
Atlantic Biologicals Corps
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
THEOPHYLLINE ANHYDROUS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-0644
Application NumberANDA085186
Product Classification
M
Marketing Category
C73584
G
Generic Name
THEOPHYLLINE ANHYDROUS
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2010
FDA Product Classification
INGREDIENTS (6)
THEOPHYLLINE ANHYDROUSActive
Quantity: 80 mg in 15 mL
Code: 0I55128JYK
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT