Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rubicon Research Private Limited
Advagen Pharma Ltd
737796233
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lithium
Product Details
NDC Product Code
72888-172Application Number
ANDA218036Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 25, 2023WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Lithium citrateActive
Code: 5Z6E9K79YVClass: ACTIMQuantity: 8 meq in 5 mL