Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Lohxa
Lohxa
079872715
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Details
NDC Product Code
70166-630Application Number
ANDA087708Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 10, 2019ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.75 mL in 5 mL
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
MALTOLInactive
Code: 3A9RD92BS4Class: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
AtropineActive
Code: 03J5ZE7KA5Class: ACTIBQuantity: 0.025 mg in 5 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
DiphenoxylateActive
Code: W24OD7YW48Class: ACTIBQuantity: 2.5 mg in 5 mL