Manufacturing Establishments (1)
Lannett Company, Inc.
OMNIVIUM PHARMACEUTICALS LLC.
006422406
Products (1)
cocaine hydrochloride nasal
81665-301
NDA209575
NDA authorized generic (C73605)
TOPICAL
September 25, 2023
CocaineActive
Code: XH8T8T6WZHClass: ACTIBQuantity: 40 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT