FDA Orange Book · active-ingredient family
Hydrocortisone valerate
Hydrocortisone valerate is approved as 2 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:WESTCORT · NDA 018726
2
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| WESTCORTRLD | SUN PHARM INDS INC | NDA 018726 | — | Aug 08, 1983 | |
| WESTCORTRLD | SUN PHARM INDS INC | NDA 017950 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCORTISONE VALERATE | ENCUBE ETHICALS | ANDA 211047 | AB | Nov 04, 2021 | |
| HYDROCORTISONE VALERATE | COSETTE PHARMS NC | ANDA 213724 | AB | Feb 11, 2021 | |
| HYDROCORTISONE VALERATE | COSETTE PHARMS NC | ANDA 211764 | AB | Mar 04, 2020 | |
| HYDROCORTISONE VALERATE | LUPIN | ANDA 210307 | AB | Aug 15, 2019 | |
| HYDROCORTISONE VALERATE | GLENMARK PHARMS LTD | ANDA 211750 | — | Dec 14, 2018 | |
| HYDROCORTISONE VALERATE | GLENMARK PHARMS LTD | ANDA 211129 | — | Oct 12, 2018 | |
| HYDROCORTISONE VALERATE | FOUGERA PHARMS | ANDA 075085 | — | Jul 31, 2001 | |
| HYDROCORTISONE VALERATE | PADAGIS ISRAEL | ANDA 075666 | — | May 24, 2000 | |
| HYDROCORTISONE VALERATE | SUN PHARMA CANADA | ANDA 075042 | AB | Aug 25, 1998 | |
| HYDROCORTISONE VALERATE | SUN PHARMA CANADA | ANDA 075043 | AB | Aug 25, 1998 | |
| HYDROCORTISONE VALERATE | COSETTE | ANDA 074489 | — | Aug 12, 1998 |
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 valerate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
