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FDA Approval

Neomycin and Polymyxin B Sulfates and Hydrocortisone

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

FDA Approval Summary

Company
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Effective Date
June 16, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone(10 mg in 1 mL)
Neomycin(3.5 mg in 1 mL)
Polymyxin B(10000 [USP'U] in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

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

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product Details

NDC Product Code
68071-4229
Application Number
ANDA064065
Marketing Category
ANDA (C73584)
Route of Administration
AURICULAR (OTIC)
Effective Date
June 16, 2023
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
HydrocortisoneActive
Code: WI4X0X7BPJClass: ACTIBQuantity: 10 mg in 1 mL
THIMEROSALInactive
Code: 2225PI3MOVClass: IACT
NeomycinActive
Code: 057Y626693Class: ACTIMQuantity: 3.5 mg in 1 mL
Polymyxin BActive
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 mL
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