FDA Orange Book · active-ingredient family
Acetohexamide
Acetohexamide is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DYMELOR · NDA 013378
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DYMELOR×2 | LILLY | NDA 013378 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACETOHEXAMIDE | WATSON LABS TEVA | ANDA 071893 | — | Nov 25, 1987 | |
| ACETOHEXAMIDE | WATSON LABS TEVA | ANDA 071894 | — | Nov 25, 1987 | |
| ACETOHEXAMIDE×2 | ANI PHARMS | ANDA 070870 | — | Feb 09, 1987 | |
| ACETOHEXAMIDE | USL PHARMA | ANDA 070753 | — | Nov 03, 1986 | |
| ACETOHEXAMIDE | USL PHARMA | ANDA 070754 | — | Nov 03, 1986 |
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.
Acetohexamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
