Theophylline
Theophylline Oral Solution, USP 80 mg/15 mL Rx Only
Approved
Approval ID
78a99bfe-6ebe-4ace-80b0-ee019921435e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2020
Manufacturers
FDA
Tris Pharma Inc
DUNS: 947472119
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 Code27808-033
Application NumberANDA091586
Product Classification
M
Marketing Category
C73584
G
Generic Name
Theophylline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
THEOPHYLLINE ANHYDROUSActive
Quantity: 80 mg in 15 mL
Code: 0I55128JYK
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT