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Serving leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Boehringer Ingelheim
Federal Trade Commission
Argus Health
Express Scripts

Generated: February 17, 2018

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 three 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 one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.
Summary for 062055
Applicant:Ani Pharms Inc
Ingredient:erythromycin ethylsuccinate
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062055
Physiological EffectDecreased Sebaceous Gland Activity
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 N 62559-440-02
ERYTHROMYCIN ETHYLSUCCINATE erythromycin ethylsuccinate GRANULE;ORAL 062055 ANDA ANI Pharmaceuticals, Inc. 62559-440 N 62559-440-01

Profile for product number 001

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

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