FDA Orange Book · active-ingredient family
Hydrocortisone; urea
Hydrocortisone; urea is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALPHADERMRLD | BIOGLAN | ANDA 086008 | — | Approved Prior to Jan 1, 1982 | |
| CALMURID HC | PHARMACIA AND UPJOHN | ANDA 083947 | — | Approved Prior to Jan 1, 1982 |
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; urea — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
