Registrants (1)
Teligent Pharma, Inc.
011036910
Manufacturing Establishments (1)
Teligent Pharma, Inc.
Teligent Pharma, Inc.
Teligent Pharma, Inc.
011036910
Products (1)
Hydrocortisone Butyrate
52565-087
ANDA209556
ANDA (C73584)
TOPICAL
September 10, 2019
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
Hydrocortisone butyrateActive
Code: 05RMF7YPWNClass: ACTIBQuantity: 1 mg in 1 mL
CETETH-20Inactive
Code: I835H2IHHXClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT