Registrants (1)
Lyne Laboratories, Inc.
053510459
Manufacturing Establishments (1)
Lyne Laboratories, Inc.
Rising Pharma Holdings, Inc.
Lyne Laboratories, Inc.
053510459
Products (1)
Dexamethasone
64980-509
ANDA090891
ANDA (C73584)
ORAL
October 3, 2023
BENZOIC ACIDInactive
Code: 8SKN0B0MIMClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 0.5 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT