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FDA Approval

erythromycin

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

FDA Approval Summary

Company
REMEDYREPACK INC.
DUNS: 829572556
Effective Date
January 5, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Erythromycin(5 mg in 1 g)

Products1

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

erythromycin

Product Details

NDC Product Code
70518-0392
Application Number
ANDA062447
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
January 5, 2024
Code: 63937KV33DClass: ACTIBQuantity: 5 mg in 1 g
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
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