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Erythromycin

Approved
Approval ID

018c94b5-8379-4b08-a18c-fad9c0219c0b

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-0946
Application NumberANDA064187
Product Classification
M
Marketing Category
C73584
G
Generic Name
erythromycin
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 29, 2010
FDA Product Classification

INGREDIENTS (4)

ALCOHOLInactive
Quantity: 71.5 mg in 1 1
Code: 3K9958V90M
Classification: IACT
ERYTHROMYCINActive
Quantity: 20 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

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Erythromycin - FDA Drug Approval Details