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FDA Approval

Necon 0.5/35

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

FDA Approval Summary

Company
Effective Date
September 5, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Registrants1

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

PSS World Medical, Inc.

101822862

Manufacturing Establishments6

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

Dispensing Solutions, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

066070785

PSS World Medical, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

791528623

STAT RX USA LLC

Rebel Distributors Corp

PSS World Medical, Inc.

786036330

Keltman Pharmaceuticals, Inc.

Rebel Distributors Corp

PSS World Medical, Inc.

362861077

Rebel Distirbutors Corp.

Rebel Distributors Corp

PSS World Medical, Inc.

118802834

SCRIPT PAK

Rebel Distributors Corp

PSS World Medical, Inc.

964420108

Products1

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

Necon 0.5/35

Product Details

NDC Product Code
42254-287
Application Number
ANDA070686
Marketing Category
ANDA (C73584)
Effective Date
March 9, 2012
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