Registrants (1)
LUPIN LIMITED
675923163
Manufacturing Establishments (1)
LUPIN LIMITED
Lupin Pharmaceuticals, Inc.
LUPIN LIMITED
650595213
Products (1)
Hydrocortisone Butyrate
68180-951
ANDA210209
ANDA (C73584)
TOPICAL
December 13, 2019
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
Hydrocortisone butyrateActive
Code: 05RMF7YPWNClass: ACTIBQuantity: 1 mg in 1 mL
CETETH-20Inactive
Code: I835H2IHHXClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT