MedPath
FDA Approval

Hydrocortisone Butyrate

April 6, 2021

HUMAN PRESCRIPTION DRUG LABEL

Manufacturing Establishments (1)

Taro Pharmaceutical Industries Ltd.

Taro Pharmaceuticals U.S.A., Inc.

600072078

Products (3)

Hydrocortisone Butyrate

51672-4083

ANDA076842

ANDA (C73584)

TOPICAL

April 6, 2021

mineral oilInactive
Code: T5L8T28FGPClass: IACT
high density polyethyleneInactive
Code: UG00KM4WR7Class: IACT
Code: 05RMF7YPWNClass: ACTIBQuantity: 1 mg in 1 g

Hydrocortisone Butyrate

51672-4061

ANDA076364

ANDA (C73584)

TOPICAL

April 6, 2021

Code: 05RMF7YPWNClass: ACTIBQuantity: 1 mg in 1 mL
glycerinInactive
Code: PDC6A3C0OXClass: IACT
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
isopropyl alcoholInactive
Code: ND2M416302Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
trisodium citrate dihydrateInactive
Code: B22547B95KClass: IACT

Hydrocortisone Butyrate

51672-4074

ANDA076654

ANDA (C73584)

TOPICAL

April 6, 2021

anhydrous citric acidInactive
Code: XF417D3PSLClass: IACT
light mineral oilInactive
Code: N6K5787QVPClass: IACT
Code: 05RMF7YPWNClass: ACTIBQuantity: 1 mg in 1 g
ceteth-20Inactive
Code: I835H2IHHXClass: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
propylparabenInactive
Code: Z8IX2SC1OHClass: IACT
butylparabenInactive
Code: 3QPI1U3FV8Class: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
petrolatumInactive
Code: 4T6H12BN9UClass: IACT
anhydrous trisodium citrateInactive
Code: RS7A450LGAClass: IACT
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