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
NDC Product Code17856-0644
Application NumberANDA085186
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 28, 2010
Generic NameTHEOPHYLLINE ANHYDROUS
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