ELIXOPHYLLIN
ELIXOPHYLLIN Elixir(Theophylline Oral Solution, USP)(brand of theophylline anhydrous)Rx Only
Approved
Approval ID
b488f996-2f80-438a-8333-b837f9acd4fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2018
Manufacturers
FDA
Nostrum Laboratories, Inc.
DUNS: 791055549
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 Code70408-644
Application NumberANDA085186
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 29, 2016
Generic NameTHEOPHYLLINE ANHYDROUS
INGREDIENTS (7)
THEOPHYLLINE ANHYDROUSActive
Quantity: 80 mg in 15 mL
Code: 0I55128JYK
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT