Orange Book product · Brand (NDA)
LOCOID
HYDROCORTISONE BUTYRATE
At a glance
Mar 31, 1982
Approved
Brand (NDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 31, 1982
44 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCORTISONE BUTYRATE
Strength
0.1%
Dosage form
CREAM
Route
TOPICAL
TE code
AB1
Application
NDA 018514
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2007LOCOIDBrand (NDA)
NDA 022076 · BAUSCH
- 1997LOCOID LIPOCREAMBrand (NDA)
NDA 020769 · PRECISION DERMAT
- 1988LOCOIDBrand (NDA)
NDA 019819 · YAMANOUCHI
- 1987LOCOIDBrand (NDA)
NDA 019116 · BAUSCH
- 1984LOCOIDBrand (NDA)
NDA 019106 · YAMANOUCHI
- 1983LOCOIDBrand (NDA)
NDA 018795 · YAMANOUCHI
- 1982LOCOIDBrand (NDA)
NDA 018652 · PRECISION DERMAT
- 2018HYDROCORTISONE BUTYRATEGeneric (ANDA)
ANDA 210209 · LUPIN
- 2017HYDROCORTISONE BUTYRATEGeneric (ANDA)
ANDA 205134 · ACTAVIS MID ATLANTIC
- 2017HYDROCORTISONE BUTYRATEGeneric (ANDA)
ANDA 209556 · THE J MOLNER
- 2013HYDROCORTISONE BUTYRATEGeneric (ANDA)
ANDA 202145 · GLENMARK PHARMS LTD
- 2005HYDROCORTISONE BUTYRATEGeneric (ANDA)
ANDA 076654 · TARO PHARM INDS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
