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Erythromycin Ethylsuccinate

Erythromycin Ethylsuccinate for Oral Suspension, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Approved
Approval ID

46f74c4f-10fc-44cf-aec4-d113f49149bc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 2, 2024

Manufacturers
FDA

Nivagen Pharmaceuticals, Inc.

DUNS: 052032418

Products 2

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

Erythromycin Ethylsuccinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75834-295
Application NumberANDA216212
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin Ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2022
FDA Product Classification

INGREDIENTS (6)

ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 200 mg in 5 mL
Code: 1014KSJ86F
Classification: ACTIM
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT

Erythromycin Ethylsuccinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75834-294
Application NumberANDA216212
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin Ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2022
FDA Product Classification

INGREDIENTS (6)

CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 400 mg in 5 mL
Code: 1014KSJ86F
Classification: ACTIM
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

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Erythromycin Ethylsuccinate - FDA Drug Approval Details