FDA Orange Book · active-ingredient family
Hydrocortisone acetate; neomycin sulfate
Hydrocortisone acetate; neomycin sulfate is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEO-CORTEF×2 | PHARMACIA AND UPJOHN | ANDA 061049 | — | Approved Prior to Jan 1, 1982 | |
| NEO-CORTEF×2 | PHARMACIA AND UPJOHN | ANDA 060610 | — | Approved Prior to Jan 1, 1982 | |
| NEO-CORTEF×3 | PHARMACIA AND UPJOHN | ANDA 060751 | — | Approved Prior to Jan 1, 1982 | |
| COR-OTICIN | EPIC PHARMA LLC | ANDA 060188 | — | Approved Prior to Jan 1, 1982 | |
| NEO-CORTEF×2 | PHARMACIA AND UPJOHN | ANDA 060612 | — | 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; neomycin sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
