Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062055

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NDA 062055 describes ERYTHROMYCIN ETHYLSUCCINATE, which is a drug marketed by Ani Pharms Inc, Alpharma Us Pharms, Dista, Naska, Parke Davis, Pharmafair, Arbor Pharms Llc, Barr, and Mylan, and is included in eleven NDAs. It is available from two 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 062055
Tradename:ERYTHROMYCIN ETHYLSUCCINATE
Applicant:Ani Pharms Inc
Ingredient:erythromycin ethylsuccinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062055
Suppliers and Packaging for NDA: 062055
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN ETHYLSUCCINATE erythromycin ethylsuccinate GRANULE;ORAL 062055 ANDA ANI Pharmaceuticals, Inc. 62559-440 62559-440-01 100 mL in 1 BOTTLE (62559-440-01)
ERYTHROMYCIN ETHYLSUCCINATE erythromycin ethylsuccinate GRANULE;ORAL 062055 ANDA ANI Pharmaceuticals, Inc. 62559-440 62559-440-02 200 mL in 1 BOTTLE (62559-440-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 400MG BASE/5ML
Approval Date:Nov 2, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Nov 2, 2018TE:AB2RLD:No

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Serving leading biopharmaceutical companies globally:

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McKesson
McKinsey
Dow

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