Product Details for ANDA 062055
ERYTHROMYCIN ETHYLSUCCINATE (ERYTHROMYCIN ETHYLSUCCINATE)
EQ 200MG BASE/5ML
Marketing Status: Prescription
EQ 200MG BASE/5ML
Marketing Status: Prescription
EQ 400MG BASE/5ML
Marketing Status: Prescription
EQ 200MG BASE/5ML
Marketing Status: Prescription
Active Ingredient: ERYTHROMYCIN ETHYLSUCCINATE
Proprietary Name: ERYTHROMYCIN ETHYLSUCCINATE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 200MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A062055
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ERYTHROMYCIN ETHYLSUCCINATE (ERYTHROMYCIN ETHYLSUCCINATE)
Proprietary Name: ERYTHROMYCIN ETHYLSUCCINATE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 200MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A062055
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 200MG BASE/5ML
Marketing Status: Prescription
Active Ingredient: ERYTHROMYCIN ETHYLSUCCINATE
Proprietary Name: ERYTHROMYCIN ETHYLSUCCINATE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 200MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A062055
Product Number: 003
Approval Date: Nov 2, 2018
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ERYTHROMYCIN ETHYLSUCCINATE (ERYTHROMYCIN ETHYLSUCCINATE)
Proprietary Name: ERYTHROMYCIN ETHYLSUCCINATE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 200MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A062055
Product Number: 003
Approval Date: Nov 2, 2018
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 400MG BASE/5ML
Marketing Status: Prescription
Active Ingredient: ERYTHROMYCIN ETHYLSUCCINATE
Proprietary Name: ERYTHROMYCIN ETHYLSUCCINATE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 400MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A062055
Product Number: 002
Approval Date: Nov 2, 2018
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ERYTHROMYCIN ETHYLSUCCINATE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 400MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A062055
Product Number: 002
Approval Date: Nov 2, 2018
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information