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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 216212


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NDA 216212 describes ERYTHROMYCIN ETHYLSUCCINATE, which is a drug marketed by Amneal Pharms, Ani Pharms, Cadila Pharms Ltd, Endo Operations, Alpharma Us Pharms, Dista, Naska, Parke Davis, Pharmafair, Aurobindo Pharma Usa, Azurity, and Barr, and is included in fourteen NDAs. It is available from five 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 216212
Pharmacology for NDA: 216212
Suppliers and Packaging for NDA: 216212
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN ETHYLSUCCINATE erythromycin ethylsuccinate GRANULE;ORAL 216212 ANDA Cadila Pharmaceuticals Limited 71209-102 71209-102-21 100 mL in 1 BOTTLE (71209-102-21)
ERYTHROMYCIN ETHYLSUCCINATE erythromycin ethylsuccinate GRANULE;ORAL 216212 ANDA Cadila Pharmaceuticals Limited 71209-103 71209-103-21 100 mL in 1 BOTTLE (71209-103-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Nov 21, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 400MG BASE/5ML
Approval Date:Nov 21, 2022TE:ABRLD:No

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