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FDA Approval

NAFCILLIN SODIUM

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

FDA Approval Summary

Company
Effective Date
November 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Nafcillin(1 g in 1 1)

Manufacturing Establishments1

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

Steriscience Specialties Private Limited - Beta Lactam Division

Armas Pharmaceuticals Inc.

650391548

Products2

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

NAFCILLIN SODIUM

Product Details

NDC Product Code
72485-405
Application Number
ANDA200002
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
November 1, 2023
NafcillinActive
Code: 49G3001BCKClass: ACTIMQuantity: 1 g in 1 1
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT

NAFCILLIN SODIUM

Product Details

NDC Product Code
72485-406
Application Number
ANDA200002
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
November 1, 2023
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
NafcillinActive
Code: 49G3001BCKClass: ACTIMQuantity: 2 g in 1 1
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