FDA Orange Book · active-ingredient family
Betamethasone acetate; betamethasone sodium phosphate
Betamethasone acetate; betamethasone sodium phosphate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CELESTONE SOLUSPAN · NDA 014602
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CELESTONE SOLUSPANRLD | ORGANON | NDA 014602 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | HIKMA | ANDA 077838 | AB | Jan 17, 2023 | |
| BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE | AM REGENT | ANDA 090747 | AB | Jul 31, 2009 |
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.
Betamethasone acetate; betamethasone sodium phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
