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FDA Approval

Nafcillin

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

FDA Approval Summary

Company
Effective Date
October 18, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Nafcillin(2 g in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

ACIC Fine Chemicals

246104632

Manufacturing Establishments1

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

Antibiotice SA

Claris Lifesciences, Inc.

ACIC Fine Chemicals

644984809

Products2

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

Nafcillin

Product Details

NDC Product Code
36000-176
Application Number
ANDA090560
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
October 18, 2011
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
NafcillinActive
Code: 49G3001BCKClass: ACTIMQuantity: 2 g in 1 1

Nafcillin

Product Details

NDC Product Code
36000-175
Application Number
ANDA090560
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
October 18, 2011
NafcillinActive
Code: 49G3001BCKClass: ACTIMQuantity: 1 g in 1 1
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
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