Registrants (1)
Akorn Operating Company LLC
117693100
Manufacturing Establishments (1)
Akorn
Akorn
Akorn Operating Company LLC
117696873
Products (1)
Promethazine Hydrochloride and Phenylephrine Hydrochloride
50383-802
ANDA040675
ANDA (C73584)
ORAL
May 27, 2022
PromethazineActive
Code: R61ZEH7I1IClass: ACTIBQuantity: 6.25 mg in 5 mL
SUCROSEInactive
Code: C151H8M554Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 5 mg in 5 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT