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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 211204

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NDA 211204 describes ERYTHROMYCIN ETHYLSUCCINATE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Par Pharm Inc, Alpharma Us Pharms, Dista, Naska, Parke Davis, Pharmafair, Arbor Pharms Llc, Barr, and Mylan, and is included in thirteen NDAs. It is available from four suppliers. Additional details are available on the ERYTHROMYCIN ETHYLSUCCINATE profile page.

The generic ingredient in ERYTHROMYCIN ETHYLSUCCINATE is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.
Summary for 211204
Tradename:ERYTHROMYCIN ETHYLSUCCINATE
Applicant:Amneal Pharms
Ingredient:erythromycin ethylsuccinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211204
Suppliers and Packaging for NDA: 211204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN ETHYLSUCCINATE erythromycin ethylsuccinate GRANULE;ORAL 211204 ANDA Amneal Pharmaceuticals NY LLC 69238-1503 69238-1503-1 100 mL in 1 BOTTLE (69238-1503-1)
ERYTHROMYCIN ETHYLSUCCINATE erythromycin ethylsuccinate GRANULE;ORAL 211204 ANDA Amneal Pharmaceuticals NY LLC 69238-1504 69238-1504-2 100 mL in 1 BOTTLE (69238-1504-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Nov 1, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 400MG BASE/5ML
Approval Date:Nov 1, 2019TE:ABRLD:No

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