FDA Orange Book · active-ingredient family
Erythromycin ethylsuccinate; sulfisoxazole acetyl
Erythromycin ethylsuccinate; sulfisoxazole acetyl 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:PEDIAZOLE · NDA 050529
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · granule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PEDIAZOLE | ROSS LABS | NDA 050529 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERYZOLE | ALRA | ANDA 062758 | — | Jun 15, 1988 | |
| ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL | BARR | ANDA 062759 | — | May 20, 1988 |
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.
Erythromycin ethylsuccinate; sulfisoxazole acetyl — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
