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FDA Approval

ERYTHROMYCIN ETHYLSUCCINATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 24, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Erythromycin(400 mg in 5 mL)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ERYTHROMYCIN ETHYLSUCCINATE

Product Details

NDC Product Code
52536-130
Application Number
NDA050207
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 24, 2020
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
CaramelInactive
Code: T9D99G2B1RClass: IACT
Code: 1014KSJ86FClass: ACTIMQuantity: 400 mg in 5 mL
sucroseInactive
Code: C151H8M554Class: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
xanthan gumInactive
Code: TTV12P4NEEClass: IACT

ERYTHROMYCIN ETHYLSUCCINATE

Product Details

NDC Product Code
52536-132
Application Number
NDA050207
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 24, 2020
Code: 1014KSJ86FClass: ACTIMQuantity: 200 mg in 5 mL
CaramelInactive
Code: T9D99G2B1RClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
sucroseInactive
Code: C151H8M554Class: IACT
xanthan gumInactive
Code: TTV12P4NEEClass: IACT
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