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Erythromycin Ethylsuccinate

Approved
Approval ID

6d8c343b-30d9-4cdb-8f55-2a20983a71c1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 29, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

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 Code54868-0018
Application NumberANDA061904
Product Classification
M
Marketing Category
C73584
G
Generic Name
erythromycin ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2010
FDA Product Classification

INGREDIENTS (7)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 400 mg in 1 1
Code: 1014KSJ86F
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT

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Erythromycin Ethylsuccinate - FDA Drug Approval Details