Lithium
These highlights do not include all the information needed to use LITHIUM ORAL SOLUTION safely and effectively. See full prescribing information for LITHIUM ORAL SOLUTION. LITHIUM oral solution, for oral use Initial U.S. Approval: 1970
Approved
Approval ID
ff9baf45-830f-4a8a-8986-5caeaa1b38cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2023
Manufacturers
FDA
Advagen Pharma Ltd
DUNS: 051627256
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lithium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-172
Application NumberANDA218036
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lithium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 25, 2023
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LITHIUM CITRATEActive
Quantity: 8 meq in 5 mL
Code: 5Z6E9K79YV
Classification: ACTIM