FDA Orange Book · active-ingredient family
Erythromycin estolate
Erythromycin estolate is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ILOSONE · NDA 050010
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension, suspension, suspension/drops, tablet, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ILOSONE×2 | LILLY | NDA 050010 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERYTHROMYCIN ESTOLATE×2 | COSETTE | ANDA 062169 | — | Oct 17, 1990 | |
| ERYTHROMYCIN ESTOLATE | LIFE LABS | ANDA 062362 | — | Dec 17, 1982 | |
| ERYTHROMYCIN ESTOLATE | ALPHARMA US PHARMS | ANDA 062409 | — | Dec 16, 1982 | |
| ERYTHROMYCIN ESTOLATE | ALPHARMA US PHARMS | ANDA 062353 | — | Nov 18, 1982 | |
| ERYTHROMYCIN ESTOLATE×2 | BARR | ANDA 062162 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN ESTOLATE | IVAX SUB TEVA PHARMS | ANDA 062237 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN ESTOLATE | WATSON LABS | ANDA 062087 | — | Approved Prior to Jan 1, 1982 | |
| ILOSONE×2 | LILLY | ANDA 061897 | — | Approved Prior to Jan 1, 1982 | |
| ILOSONE | DISTA | ANDA 061893 | — | Approved Prior to Jan 1, 1982 | |
| ILOSONE×3 | LILLY | ANDA 061894 | — | Approved Prior to Jan 1, 1982 | |
| ILOSONE×2 | DISTA | ANDA 061895 | — | Approved Prior to Jan 1, 1982 | |
| ILOSONE | LILLY | ANDA 061896 | — | 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.
Erythromycin estolate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
