FDA Orange Book · active-ingredient family
Triamcinolone diacetate
Triamcinolone diacetate is approved as 4 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ARISTOCORT · NDA 012802
4
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARISTOCORTRLD | FOSUN PHARMA | NDA 012802 | — | Approved Prior to Jan 1, 1982 | |
| ARISTOCORT | FOSUN PHARMA | NDA 011685 | — | Approved Prior to Jan 1, 1982 | |
| ARISTOCORT | ASTELLAS | NDA 011960 | — | Approved Prior to Jan 1, 1982 | |
| KENACORT | DELCOR ASSET CORP | NDA 012515 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIAMCINOLONE DIACETATE | EPIC PHARMA LLC | ANDA 085122 | — | Approved Prior to Jan 1, 1982 | |
| TRIAMCINOLONE DIACETATE | EPIC PHARMA LLC | ANDA 086394 | — | Approved Prior to Jan 1, 1982 | |
| TRIAMCINOLONE DIACETATE | WATSON LABS | ANDA 084072 | — | Approved Prior to Jan 1, 1982 | |
| TRIAMCINOLONE DIACETATE | WATSON LABS | ANDA 085529 | — | 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.
Triamcinolone diacetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
