FDA Orange Book · active-ingredient family
Hydrocortisone acetate; pramoxine hydrochloride
Hydrocortisone acetate; pramoxine hydrochloride is approved in 8 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1% | GENUS | ANDA 089440 | — | May 17, 1988 | |
| EPIFOAM | MYLAN SPECIALITY LP | ANDA 086457 | BX | Approved Prior to Jan 1, 1982 | |
| PROCTOFOAM HCRLD | MYLAN SPECIALITY LP | ANDA 086195 | BX | Approved Prior to Jan 1, 1982 | |
| PRAMOSONE | LEGACY PHARMA | ANDA 083778 | — | Approved Prior to Jan 1, 1982 | |
| PRAMOSONE | LEGACY PHARMA | ANDA 085368 | — | Approved Prior to Jan 1, 1982 | |
| PRAMOSONE | FERNDALE LABS | ANDA 083213 | — | Approved Prior to Jan 1, 1982 | |
| PRAMOSONE | LEGACY PHARMA | ANDA 085980 | — | Approved Prior to Jan 1, 1982 | |
| PRAMOSONE | LEGACY PHARMA | ANDA 085979 | — | 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 acetate; pramoxine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
