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FDA Orange Book · active-ingredient family

Erythromycin ethylsuccinate

Erythromycin ethylsuccinate is approved as 2 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:E.E.S. · NDA 050207

2

Brand (NDA)

20

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · granule, suspension, suspension/drops, tablet, tablet, chewable

ProductApplicantApplicationTEApproved
E.E.S.RLD×3CARNEGIENDA 050207ABApproved Prior to Jan 1, 1982
E.E.S.×2AZURITYNDA 050297—Approved Prior to Jan 1, 1982

Generic (ANDA) products (20)

ProductApplicantApplicationTEApproved
ERYTHROMYCIN ETHYLSUCCINATE×2CADILA PHARMS LTDANDA 216212ABNov 21, 2022
ERYTHROMYCIN ETHYLSUCCINATE×2AMNEAL PHARMSANDA 211204ABNov 01, 2019
ERYTHROMYCIN ETHYLSUCCINATE×2PH HEALTHANDA 211991—Oct 23, 2019
ERYTHROMYCIN ETHYLSUCCINATEAUROBINDO PHARMA USAANDA 062847—Sep 14, 1988
ERYTHROMYCIN ETHYLSUCCINATENASKAANDA 062674—Mar 10, 1987
ERYTHROMYCIN ETHYLSUCCINATEPHARMAFAIRANDA 062559—Mar 15, 1985
ERYTHROMYCIN ETHYLSUCCINATEPHARMAFAIRANDA 062558—Mar 15, 1985
ERYTHROMYCIN ETHYLSUCCINATE×3ANI PHARMSANDA 062055ABApproved Prior to Jan 1, 1982
PEDIAMYCIN×2ROSS LABSANDA 062305—Approved Prior to Jan 1, 1982
E-MYCIN E×2PHARMACIA AND UPJOHNANDA 062198—Approved Prior to Jan 1, 1982
E.E.S. 200×2ARBOR PHARMS LLCANDA 061639—Approved Prior to Jan 1, 1982
ERYTHROMYCIN ETHYLSUCCINATE×2ALPHARMA US PHARMSANDA 062200—Approved Prior to Jan 1, 1982
ERYTHROMYCIN ETHYLSUCCINATE×2DISTAANDA 062177—Approved Prior to Jan 1, 1982
ERYTHROMYCIN ETHYLSUCCINATE×2PARKE DAVISANDA 062231—Approved Prior to Jan 1, 1982
PEDIAMYCIN×2ARBOR PHARMS LLCANDA 062304—Approved Prior to Jan 1, 1982
WYAMYCIN E×2WYETH AYERSTANDA 062123—Approved Prior to Jan 1, 1982
PEDIAMYCINROSS LABSANDA 062306—Approved Prior to Jan 1, 1982
E.E.S. 400×2CARNEGIEANDA 061905—Approved Prior to Jan 1, 1982
ERYTHROMYCIN ETHYLSUCCINATEBARRANDA 062256—Approved Prior to Jan 1, 1982
ERYTHROMYCIN ETHYLSUCCINATECARNEGIEANDA 061904BXApproved 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 ethylsuccinate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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