FDA Orange Book · active-ingredient family
Hydrocortisone butyrate
Hydrocortisone butyrate is approved as 8 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOCOID · NDA 022076
8
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion, ointment, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOCOIDRLD | BAUSCH | NDA 022076 | — | May 18, 2007 | |
| LOCOID LIPOCREAMRLD | PRECISION DERMAT | NDA 020769 | AB2 | Sep 08, 1997 | |
| LOCOIDRLD | BAUSCH | NDA 019116 | AT | Feb 25, 1987 | |
| LOCOIDRLD | PRECISION DERMAT | NDA 018652 | — | Oct 29, 1982 | |
| LOCOIDRLD | BAUSCH | NDA 018514 | AB1 | Mar 31, 1982 | |
| LOCOID | YAMANOUCHI | NDA 019819 | — | Sep 15, 1988 | |
| LOCOID | YAMANOUCHI | NDA 019106 | — | Jul 03, 1984 | |
| LOCOID | YAMANOUCHI | NDA 018795 | — | Jan 07, 1983 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCORTISONE BUTYRATE | LUPIN | ANDA 210209 | AB | Aug 17, 2018 | |
| HYDROCORTISONE BUTYRATE | ACTAVIS MID ATLANTIC | ANDA 205134 | AB2 | Dec 08, 2017 | |
| HYDROCORTISONE BUTYRATE | THE J MOLNER | ANDA 209556 | AB | Nov 21, 2017 | |
| HYDROCORTISONE BUTYRATE | GLENMARK PHARMS LTD | ANDA 202145 | — | Sep 27, 2013 | |
| HYDROCORTISONE BUTYRATE | TARO PHARM INDS | ANDA 076654 | AB1 | Aug 03, 2005 | |
| HYDROCORTISONE BUTYRATE | TARO | ANDA 076842 | — | Dec 27, 2004 | |
| HYDROCORTISONE BUTYRATE | TARO PHARM INDS | ANDA 076364 | AT | Jan 14, 2004 |
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.
Hydrocortisone butyrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
